FDA Adverse Event
Malfunction
Summary report: N
ERBE
MDR report key: 16060539
·
Received December 28, 2022
Report
- Report Number
- 16060539
- Event Type
- Malfunction
- Date Received
- December 28, 2022
- Date of Event
- December 6, 2022
- Report Date
- December 7, 2022
- Manufacturer
- ERBE ELEKTROMEDIZIN GMBH
- Product Code
- FEQ
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- OH
- Reporter Occupation
- RISK MANAGER
- Health Professional
- N
Narratives
Description of Event or Problem · 0
WHEN SETTING UP FOR CASES THE ENDO RNS IN OR1 TODAY TRIED 2 DIFFERENT ERBEFLO CLEVERCAP TUBING SETS FROM LOT #20220225-PG AND NEITHER WOULD ALLOW THE CONTINUOUS IRRIGATION TO FLOW (THEY COULDN'T SEE ANY HOLES, THEY TRIED DIFFERENT WATER BOTTLES, TURNED THE MACHINES OFF AND BACK ON, ETC. WITH NO SUCCESS). THEY THEN TRIED A SET FROM A DIFFERENT LOT# AND IT WORKED FINE. NOT USED ON PATIENT. PLEASE NOTE THAT THIS REPORT REPRESENTS 2 DEVICES WITH THE SAME LOT NUMBER. MANUFACTURER RESPONSE FOR PUMP, AIR, NON-MANUAL, FOR ENDOSCOPE, ERBE (PER SITE REPORTER). WILL OBTAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2093623 | ERBE | PUMP, AIR, NON-MANUAL, FOR ENDOSCOPE | FEQ | ERBE ELEKTROMEDIZIN GMBH | 20325-239 | 20220225PG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |