BIPOLAR HIGH FREQUENCY CORD, 400 CM
Report
- Report Number
- 9610617-2025-00365
- Event Type
- Injury
- Date Received
- March 12, 2025
- Date of Event
- February 10, 2025
- Report Date
- May 12, 2025
- Manufacturer
- KARL STORZ SE & CO. KG
- Product Code
- GEI
- UDI-DI
- 04048551388778
- PMA / PMN Number
- K221893
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
CORRECTION WAS MADE IN SECTION B3 AND G1 TO CORRECT THE EMAIL ADDRESS. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).
THE DEVICE IN QUESTION WAS RETURNED TO THE MANUFACTURER ON MARCH 19, 2025. THIS INFORMATION IS REFLECTED IN SECTION D9. THE EVALUATION IS ANTICIPATED, BUT NOT YET BEGUN. THE INVESTIGATION WILL BE PERFORMED BY A DESIGNATED KARL STORZ EMPLOYEE. IN ADDITION, THE FOLLOWING PRODUCTS HAVE BEEN RETURNED: - 26055EB - WORKING ELEMENT, BIPOLAR - LOT: VL05 RETURNED ON MARCH 19, 2025. - 26055GP1 - CUTTING LOOP, BIPOLAR - LOT: VM06 RETURNED ON MARCH 19, 2025. - 26055GP1 - CUTTING LOOP, BIPOLAR - LOT: UO01 RETURNED ON MARCH 19, 2025. - 011250-01 - ELECTRODE, BIPOLAR - LOT: WM22 RETURNED ON MARCH 19, 2025. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).
THE PRODUCT WAS RETURNED ON 2025-03-19 AND THE INVESTIGATION WAS COMPLETED ON 2025-05-07. THE DEVICE HISTORY RECORDS (DHR) HAVE BEEN CHECKED AND FOUND TO BE ACCORDING TO THE SPECIFICATION, VALID AT THE TIME OF PRODUCTION. THE MOST PROBABLE ROOT CAUSE IS THAT A HIGH CONTACT RESISTANCE HAS FORMED AT THE CONNECTION POINT OF THE CABLE TO THE INSTRUMENT DUE TO RESIDUES OR SIMILAR. WHEN THE HF DEVICE IS ACTIVATED, IT HEATS UP STRONGLY AT THIS POINT AND STARTS TO BURN. USER ERROR. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).
THE AFFECTED DEVICE HAS BEEN REQUESTED FOR INVESTIGATION BY THE MANUFACTURER. THE DEVICE WAS NOT YET RETURNED FOR INVESTIGATION. FURTHER INFORMATION ABOUT THE PRODUCTS AND THE EVENT IS CURRENTLY NOT AVAILABLE, BUT HAS BEEN REQUESTED. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).
THIS REPORT IS TO CLARIFY THAT THE INTERNAL REFERENCE NUMBER IN THE INITIAL REPORT FOR THIS EVENT WAS INCORRECT. A CORRECTION WAS ALREADY MADE IN THE SECOND SUPPLEMENTAL REPORT WAS MADE TO REFLECT THE CORRECT REFERENCE NUMBER (B)(4). THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).
IT WAS STATED THAT THE STERILISATION DEPARTMENT HAS REPORTED AN INCIDENT WITH STORZ MATERIALS IN THE OPERATING THEATRE. THE PROBLEM IS THAT THE RESECTION CABLE, THE WORKING ELEMENT AND TWO CUTTING LOOPS (1X REUSABLE, 1X DISPOSABLE) HAVE MELTED. THE PATIENT RECEIVED ELECTRIC SHOCKS DURING THE OPERATION. BASED ON THE INFORMATION THAT THE PATIENT RECEIVED ELECTRIC SHOCKS, THIS CASE IS DEEMED REPORTABLE. FURTHER INFORMATION WAS RECEIVED ON 07-MAR-2025: "THE PATIENT REACTED WITH STRONG MUSCLE CONTRACTIONS DURING THE OPERATION. THE HF GENERATOR DID NOT SHOW ANY ERROR MESSAGES. THE ANAESTHETIST DID NOT REPORT ANY ECG OR SIMILAR ABNORMALITIES. THE OPERATION WAS COMPLETED. AT ABOUT 3 P.M., A REPORT FROM THE CENTRAL STERILISATION DEPARTMENT: DURING CLEANING OF THE SIEVE, IT WAS FOUND THAT THE RESECTOSCOPE DEVICE/CABLE WAS DEFECTIVE AND THAT THE RESECTOSCOPE (METAL) WAS THEREFORE PROBABLY ELECTRICALLY CHARGED. THE SURGEON WAS INFORMED IMMEDIATELY. THE INSTRUMENT WAS TAKEN OUT OF SERVICE FOR INSPECTION." IT WAS FURTHERMORE INDICATED THAT THERE WAS AN UNKNOWN SURGICAL PROLONGATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1229914 | BIPOLAR HIGH FREQUENCY CORD, 400 CM | BIPOLAR HIGH FREQUENCY CORD, 400 CM | GEI | KARL STORZ SE & CO. KG | UH801 | RM02-01088 | 04048551388778 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other | 011250-01 ELECTRODE, BIPOLAR - LOT: WM22.| 26055EB WORKING ELEMENT, BIPOLAR, LOT: VL05.| 26055GP CUTTING LOOP: LOT: VM06. |