FDA Adverse Event
Malfunction
Summary report: N
GRIESHABER REVOLUTION DSP SCISSORS
MDR report key: 11841937
·
Received May 18, 2021
Report
- Report Number
- 3003398873-2021-00031
- Event Type
- Malfunction
- Date Received
- May 18, 2021
- Report Date
- May 18, 2021
- Manufacturer
- ALCON GRIESHABER AG
- Product Code
- HNF
- UDI-DI
- 07612717071070
- PMA / PMN Number
- EXEMPT
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO SAMPLE HAS BEEN RECEIVED AT MANUFACTURING FOR EVALUATION. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. THIS IS THE FIRST OF TWO REPORTS FOR THIS REPORTED EVENT. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).
Description of Event or Problem · 1
A HEALTH PROFESSIONAL REPORTED THAT MULTIPLE SCISSORS GOT STUCK TOGETHER AND WOULD NOT OPEN DURING SURGERY. THERE WAS NO REPORT OF ANY PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 739161 | GRIESHABER REVOLUTION DSP SCISSORS | SCISSORS, OPHTHALMIC | HNF | ALCON GRIESHABER AG | NA | F175813 | 07612717071070 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |