FDA Adverse Event
Malfunction
Summary report: N
ERBE
MDR report key: 20460913
·
Received October 16, 2024
Report
- Report Number
- 20460913
- Event Type
- Malfunction
- Date Received
- October 16, 2024
- Date of Event
- May 20, 2024
- Report Date
- July 10, 2024
- Manufacturer
- ERBE ELEKTROMEDIZIN GMBH
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CA
- Reporter Occupation
- RISK MANAGER
- Health Professional
- N
Narratives
Description of Event or Problem · 0
PRIOR TO ROBOT ASSISTED LAPAROSCOPIC PROSTATE SURGERY, ERBE GROUNDING PAD REF 20193-084 NEEDED TO BE CHANGED OUT TWICE. BOTH WERE LOT 230130-2405 EXP [REDACTED]. WHEN THE FIRST ONE FAULTED, IT WAS NOTED THAT THE PAD HAD GOOD ADHERENCE TO SKIN (RULING OUT A CONTACT ISSUE), IT WAS REPLACED WITH A NEW ERBE PAD THAT WAS ATTACHED TO THE ANTERIOR THIGH. THIS SECOND PAD THEN FAULTED AFTER A FEW MINUTES. WE THEN CHANGED THE PAD TO A DIFFERENT BRAND, AND IT WORKED FINE THROUGHOUT THE REMAINDER OF THE CASE. NO HARM TO PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1322620 | ERBE | ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES | GEI | ERBE ELEKTROMEDIZIN GMBH | 20193-084 | 230130-2405 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male |