FDA Adverse Event
Malfunction
Summary report: N
R/R 19CM SP BAYONET .7MM TIP
MDR report key: 4143355
·
Received October 6, 2014
Report
- Report Number
- 0001811755-2014-03489
- Event Type
- Malfunction
- Date Received
- October 6, 2014
- Date of Event
- September 8, 2014
- Report Date
- September 8, 2014
- Manufacturer
- STRYKER INSTRUMENTS-KALAMAZOO
- Product Code
- GEI
- PMA / PMN Number
- K992931
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS DISCARDED BY THE MANUFACTURER FOLLOWING EVALUATION.
Additional Manufacturer Narrative · 1
DEVICE EVALUATION IN PROGRESS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE R/R 19CM SP BAYONET .7MM TIP WAS CHIPPED DURING SERVICE INSPECTION AT THE MANUFACTURING FACILITY. NO PATIENT INVOLVEMENT, NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION, AND NO SURGICAL DELAY WERE REPORTED WITH THIS EVENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE R/R 19CM SP BAYONET .7MM TIP WAS CHIPPED DURING SERVICE INSPECTION AT THE MANUFACTURING FACILITY. NO PATIENT INVOLVEMENT, NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION, AND NO SURGICAL DELAY WERE REPORTED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 623409 | R/R 19CM SP BAYONET .7MM TIP | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | GEI | STRYKER INSTRUMENTS-KALAMAZOO | 141331 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |