FDA Adverse Event
Malfunction
Summary report: N
COAGULATING AND DISSECTING ELECTRODE
MDR report key: 17118489
·
Received June 13, 2023
Report
- Report Number
- 9610617-2023-00884
- Event Type
- Malfunction
- Date Received
- June 13, 2023
- Report Date
- June 13, 2023
- Manufacturer
- KARL STORZ SE & CO. KG
- Product Code
- KNF
- PMA / PMN Number
- K944862
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
BELATED EVALUATION AND REPORTING OF THIS COMPLAINT WAS DONE DURING RETROSPECTIVE REVIEW AS PART OF CAPA 20-0074 CORRECTIVE ACTION 6. INVESTIGATION REVEALED THAT THE ELECTRODE IS STRONGLY BENT AND BROKEN OFF AT THE DISTAL TIP. IT IS ASSUMED THAT THE ELECTRODE HAS BEEN SEVERELY MECHNAICALLY DAMAGED (BENT) AND THUS IT IS BROKEN. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID (B)(4).
Description of Event or Problem · 0
IT WAS REPORTED THAT THERE WAS EVENT WITH A ELECTRODE. ACCORDING TO THE INFORMATION RECEIVED, THE DEVICE BROKE DURING SURGERY. NO PATIENT HARM REPORTED. ADDITIONAL INFROMATION IS NOT AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1986739 | COAGULATING AND DISSECTING ELECTRODE | COAGULATING AND DISSECTING ELECTRODE | KNF | KARL STORZ SE & CO. KG | 37370DL | XR02 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |