FDA Adverse Event
Malfunction
Summary report: N
6.5MM CANNULA, 2 ROTATING STOPCOCKS
MDR report key: 3771663
·
Received April 24, 2014
Report
- Report Number
- 0002936485-2014-00267
- Event Type
- Malfunction
- Date Received
- April 24, 2014
- Date of Event
- March 27, 2014
- Report Date
- March 27, 2014
- Manufacturer
- STRYKER ENDOSCOPY-SAN JOSE
- Product Code
- NBH
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.
Additional Manufacturer Narrative · 1
THE PRODUCT WAS RETURNED AND THE FAILURE MODE WAS CONFIRMED. DURING THE VISUAL INSPECTION OF THE DEVICE A MISSING INNER O-RING SEAL WAS OBSERVED. THE PROBABLE ROOT CAUSE/S COULD BE IMPROPER STERILIZATION METHODS AND OR HANDLING. THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE REPORTED FAILURE MODE WAS CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE INTERNAL GASKET FELL APART.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE INTERNAL GASKET FELL APART.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 249584 | 6.5MM CANNULA, 2 ROTATING STOPCOCKS | ACCESSORIES,ARTHROSCOPIC | NBH | STRYKER ENDOSCOPY-SAN JOSE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |