FDA Adverse Event
Malfunction
Summary report: N
PKG, ROTATING HANDLE, RATCHET, INSULATED/SHAFT
MDR report key: 6117678
·
Received November 21, 2016
Report
- Report Number
- 0002936485-2016-01109
- Event Type
- Malfunction
- Date Received
- November 21, 2016
- Date of Event
- October 26, 2016
- Report Date
- June 16, 2017
- Manufacturer
- STRYKER ENDOSCOPY-SAN JOSE
- Product Code
- OCZ
- PMA / PMN Number
- K973259
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). VISUAL INSPECTION: A HOLE ON THE INSULATION WAS NOTICED NEAR THE DISTAL. FUNCTIONAL INSPECTION: THE INSTRUMENT FAILED THE INSULATION TESTING. THE PROBABLE ROOT CAUSE/S COULD BE NORMAL WEAR, USER MISUSE, AND IMPROPER STERILIZATION METHODS. THE FAILURE(S) IDENTIFIED IN THE INVESTIGATION IS CONSISTENT WITH THE COMPLAINT RECORD. THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE REPORTED FAILURE MODE WAS CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE INSULATION WAS DAMAGED.
Description of Event or Problem · 1
IT WAS REPORTED THE INSULATION WAS DAMAGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 767346 | PKG, ROTATING HANDLE, RATCHET, INSULATED/SHAFT | ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED | OCZ | STRYKER ENDOSCOPY-SAN JOSE | 1341852D |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |