Device product
Broncho Flexible Fiberscope, models: 11001BN1, 11002BD1, 11004BC1, and 11009BC1. " Examination and treatment of the tracheobronchial tree Contraindications for Bronchoscopy " Uncontrolled angina, uncontrolled heart failure, or serious uncontrolled ventricular arrhythmias " Uncontrolled hypertension " Bleeding disorder or use of anticoagulants.
Z-0527-2014
Product summary
- Event
- Event 66862
- Status
- Terminated
- Classification
- Class II
- Quantity
- 141 units
- Official record key
device-enforcement:Z-0527-2014
Official wording
Reason: KARL STORZ Endoscopy America, Inc. is recalling the Flexible Broncho Fiberscope or a Flexible Intubation Fiberscope with a suction port because the material used in the suction channel portion was thermoplastic polyurethane (TPU), which is not listed in STERRAD systems claims for interior endoscope lumens.
Code information: C1140, C1140E, C1160, C1160E, QKC1750, QKC1750E, QKC1694, QKC1694E
Distribution pattern: Nationwide Distribution.
Derived failure modes
-
Unknown
KARL STORZ Endoscopy America, Inc. is recalling the Flexible Broncho Fiberscope or a Flexible Intubation Fiberscope with a suction port because the material used in the suction channel portion was thermoplastic polyurethane (TPU), which is not listed in STERRAD systems claims for interior endoscope lumens.