FDA Adverse Event
Malfunction
Summary report: N
PKG, 5MM PEEK HANDLE, 45CM
MDR report key: 6482007
·
Received April 11, 2017
Report
- Report Number
- 0002936485-2017-00373
- Event Type
- Malfunction
- Date Received
- April 11, 2017
- Date of Event
- March 30, 2017
- Report Date
- August 3, 2017
- Manufacturer
- STRYKER ENDOSCOPY-SAN JOSE
- Product Code
- OCZ
- PMA / PMN Number
- K973259
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE REPORTED FAILURE MODE WAS CONFIRMED. THE REPORTED FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. ALLEGED FAILURE: INSULATION COMPROMISED EIB PEARSON PRO CAREPO# (B)(4). THE FAILURE IDENTIFIED IN THE INVESTIGATION IS CONSISTENT WITH THE COMPLAINT RECORD. THE PROBABLE ROOT CAUSE/S COULD BE NORMAL WEAR, STERILIZATION METHODS, AND USER MISUSE. GTIN: (B)(4).
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 THAT THE INSULATION WAS DAMAGED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE INSULATION WAS DAMAGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 266087 | PKG, 5MM PEEK HANDLE, 45CM | ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED | OCZ | STRYKER ENDOSCOPY-SAN JOSE | 1442304H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |