FDA Adverse Event
Injury
Summary report: N
DISPOSABLE SCOPE WARMER (6)
MDR report key: 830283
·
Received March 19, 2007
Report
- Report Number
- 2936485-2007-00019
- Event Type
- Injury
- Date Received
- March 19, 2007
- Date of Event
- February 27, 2007
- Report Date
- February 27, 2007
- Manufacturer
- STRYKER ENDOSCOPY SAN JOSE
- Product Code
- LGZ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IS ON-GOING. ONCE COMPLETE, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE SCOPE WARMER BEGAN LEAKING FROM THE INSIDE MIDDLE SEAM DURING A LAPAROSCOPIC PROCEDURE. THE SURGEON WAS UNAWARE OF THE LEAK AND INSERTED THE SCOPE INTO THE ABDOMEN OF THE PATIENT. WHEN IT WAS REALIZED THAT THE SCOPE HAD BEEN CONTAMINATED WITH SODIUM ACETATE FROM THE SCOPE WARMER, THE CASE WAS STOPPED. THE PATIENT REMAINED UNDER ANESTHESIA FOR APPROXIMATELY 90 MINUTES WHILE INFECTION CONTROL WAS CALLED TO IRRIGATE THE PATIENT'S ABDOMEN. THE PROCEDURE WAS NOT COMPLETED, AND A FOLLOW UP WILL BE NECESSARY. AS OF NOW, IT APPEARS THAT THE PATIENT DID NOT SUFFER INJURY OR INFECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DISPOSABLE SCOPE WARMER (6) | SCOPE WARMER | LGZ | STRYKER ENDOSCOPY SAN JOSE | * | 060912 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Required Intervention |