Device product
BOSS DeBakey "Gator-Grip" Needle Holder 2 mm tip, 9", Part Numbers 50-2503 and 51-2503 - Product Usage: Endoscopic cleaning brushes are single use devices intended to clean the interior of endoscopes after endoscopy procedures. The brush is threaded through the biopsy valve and pulled through the interior of the endoscope to remove debris.
Z-2767-2020
Product summary
- Event
- Event 86040
- Status
- Terminated
- Classification
- Class II
- Quantity
- 96 devices
- Official record key
device-enforcement:Z-2767-2020
Official wording
Reason: The tungsten carbide plate, which is intended to hold the sewing needle securely, can break when holding the sewing needle under pressure.
Code information: Lot Numbers: 00351415,00425391, 00374008,07702195, 08801812, 08802271, 00383211,00384765,00418258, 08804204,09900093, 09900383
Distribution pattern: Worldwide distribution - US Nationwide distribution including in the states of CA, TN, TX and the countries of England, Japan, New Zealand, South Africa, South Korea, Taiwan.
Derived failure modes
-
Unknown
The tungsten carbide plate, which is intended to hold the sewing needle securely, can break when holding the sewing needle under pressure.