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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 73736

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
March 25, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Intuitive Surgical, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

EndoWrist Stapler 45 and Stapler 30 instruments used on the da Vinci Xi systems (IS4000) with p5 software. General Surgery: The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximations, ligation, electrocautery, suturing and delivery and placement of microware and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures.

Z-1568-2016
Recall number
Z-1568-2016
Initiated
March 25, 2016
Classification
Class II
Status
Terminated
Recalling firm
Intuitive Surgical, Inc.
Quantity
43

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for unexpected motion of the Xi Stapler jaws on the da Vinci Xi System with p5 software relating to a combination of the p5 software and the surgeon quickly transitioning from the clamp to the fire pedal during use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

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Inspect official wording and provenance

Reason for recall

Potential for unexpected motion of the Xi Stapler jaws on the da Vinci Xi System with p5 software relating to a combination of the p5 software and the surgeon quickly transitioning from the clamp to the fire pedal during use.

Code information

da Vinci systems with serial numbers: SK0036 SK0292 SK0650 SK0039 SK0293 SK0652 SK0057 SK0294 SK0653 SK0101 SK0326 SK0654 SK0106 SK0358 SK0665 SK0119 SK0360 SK0701 SK0143 SK0382 SK0702 SK0144 SK0408 SK0710 SK0146 SK0438 SK0722 SK0171 SK0456 SK0728 SK0173 SK0484 SK0181 SK0492 SK0216 SK0496 SK0230 SK0516 SK0233 SK0548 SK0237 SK0552 SK0238 SK0610 SK0263 SK0612 SK0286 SK0631 SK0291 SK0649.

Distribution pattern

US Nationwide Distribution in the states of: WI, FL, OH, TX, CA, AZ, IL, MD, MN, NY, OK, HI, MO, IA, KS, PA, and AL.