FDA Adverse Event
Malfunction
Summary report: N
ELECTROSURGICAL UNIT
MDR report key: 10894450
·
Received November 24, 2020
Report
- Report Number
- 8010047-2020-09376
- Event Type
- Malfunction
- Date Received
- November 24, 2020
- Report Date
- December 21, 2020
- Manufacturer
- OLYMPUS MEDICAL SYSTEMS CORP.
- Product Code
- GEI
- UDI-DI
- 04953170287275
- PMA / PMN Number
- K030194
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO REPORT THE WITHDRAWAL OF MFR REPORT #8010047-2020-09376 AND CORRECT THE INITIAL REPORT SUBMITTED ON NOBEMBER 24, 2020.AS A RESULT OF THE INVESTIGATION, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) CONCLUDED THAT THIS COMPLAINT WAS NOT REPORTABLE EVENT.
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THERE WERE NO FURTHER DETAILS PROVIDED. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.
Description of Event or Problem · 1
OLYMPUS INSPECTED THE DEVICE AT THE SERVICE DEPARTMENT OF OLYMPUS (B)(4) AND FOUND THAT THE TOP COVER OF THE DEVICE WAS SCRATCHED. OTHER DETAILED INFORMATION WAS NOT PROVIDED. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1357010 | ELECTROSURGICAL UNIT | ELECTROSURGICAL UNIT | GEI | OLYMPUS MEDICAL SYSTEMS CORP. | UES-40 | 04953170287275 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |