FDA Adverse Event
Malfunction
Summary report: N
G/K UNIV FREE/H TARGET DEVICE
MDR report key: 141388
·
Received December 30, 1997
Report
- Report Number
- 9610622-1997-00160
- Event Type
- Malfunction
- Date Received
- December 30, 1997
- Date of Event
- November 20, 1997
- Report Date
- December 29, 1997
- Manufacturer
- HOWMEDICA INC.
- Product Code
- LXH
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
EVALUATION RESULTS RECEIVED FROM HOWMEDICA GMBH IN KIEL, GERMANY, SUGGEST THAT THIS EVENT WOULD NOT BE ASSOCIATED WITH THE DEVICE, BUT RATHER WOULD BE RELATED TO CLEANING METHODS USED BY THE CUSTOMER.
Description of Event or Problem · 1
WHEN STERILIZING TARGET DEVICE FOR 40 MINUTES @ 250 DEGREES AND DRY TIME OF 20 MINUTES, A WHITE, FLAKEY RESIDUE APPEARED ON THE SURFACE. THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | G/K UNIV FREE/H TARGET DEVICE | INSTRUMENT | LXH | HOWMEDICA INC. | NA | 347462 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other |