FDA Adverse Event
Other
Summary report: N
STRYKER 6.5MM ESST FIBEROPTIC CABLE
MDR report key: 287483
·
Received July 24, 2000
Report
- Report Number
- 2936485-2000-00075
- Event Type
- Other
- Date Received
- July 24, 2000
- Date of Event
- July 18, 2000
- Report Date
- July 21, 2000
- Manufacturer
- STRYKER ENDOSCOPY
- Product Code
- HRX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS ALLEGED THAT DURING A CASE, THERE WAS A HOLE IN THE CABLE THAT CAUSED UNIT TO FILL WITH WATER, THE DOCTOR BELIEVES THAT THIS CAUSED AN INFECTION AT THE SURGERY SITE.
Description of Event or Problem · 1
IT WAS ALLEGED THAT DURING A CASE, THERE WAS A HOLE IN THE CABLE THAT CAUSED UNIT TO FILL WITH WATER, THE DR BELIEVES THAT THIS CAUSED AN INFECTION AT THE SURGERY SITE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STRYKER 6.5MM ESST FIBEROPTIC CABLE | FIBEROPTIC CABLE | HRX | STRYKER ENDOSCOPY | 0233-050-083 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Other |