FDA Adverse Event
Malfunction
Summary report: N
4.0MM AGGRESSIVE PLUS CUTTER, FORMULA (5BX)
MDR report key: 3629914
·
Received February 14, 2014
Report
- Report Number
- 0002936485-2014-00071
- Event Type
- Malfunction
- Date Received
- February 14, 2014
- Date of Event
- January 21, 2014
- Report Date
- January 21, 2014
- Manufacturer
- STRYKER ENDOSCOPY-SAN JOSE
- Product Code
- GFF
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE REPORTED FAILURE CONDITION (TIP BREAKAGE) IS NOT CONFIRMED BECAUSE THE UNIT WAS NOT RECEIVED. MOST PROBABLE ROOT CAUSE(S) FOR THE REPORTED FAILURE MODE CAN BE ASSOCIATED, BUT NOT LIMITED TO: EXCESSIVE FORCE APPLIED BY USER, INADEQUATE SIZE SELECTED FOR THE APPLICATION, AND/OR INADEQUATE WINDOW PROFILE. THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION AND THE REPORTED FAILURE MODE COULD NOT BE 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.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE TIP OF THE AGGRESSIVE PLUS SHAVER BLADE BROKE OFF INSIDE THE PATIENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE TIP OF THE AGGRESSIVE PLUS SHAVER BLADE BROKE OFF INSIDE THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 99153 | 4.0MM AGGRESSIVE PLUS CUTTER, FORMULA (5BX) | BUR, SURGICAL, GENERAL & PLASTIC SURGERY | GFF | STRYKER ENDOSCOPY-SAN JOSE | 10104CE2 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |