BIPOLAR CABLE; TUR/TCR; STORZ; MF PLUG, L 4M

Report

Report Number: 9610614-2026-00084
Event Type: Malfunction
Date Received: May 11, 2026
Date of Event: April 8, 2026
Report Date: May 11, 2026
Manufacturer: ERBE ELEKTROMEDIZIN GMBH
Product Code: GEI
PMA / PMN Number: K190823
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

THE BIPOLAR CABLE WAS RETURNED AND EVALUATED. THE ANGLED INSTRUMENT-SIDE CONNECTOR WAS COMPLETELY DETACHED FROM THE SILICONE CABLE. THERE WERE BURN MARKS THAT APPEARED TO HAVE RESULTED FROM A VOLTAGE FLASH-OVER. BOTH INNER CABLE STRANDS WERE THOROUGHLY BURNT. BASED UPON THE EXAMINATION OF THE DAMAGED CABLE, IT APPEARS THAT THE CABLE WAS USED INTENSIVELY AND SUBJECTED TO MECHANICAL STRESS (NOTE: THE CABLE WAS USED FOR APPROXIMATELY 5 YEARS.). ADDITIONALLY, THE BURN MARKS ON THE CONTACT PIN AND THE BROKEN WIRE STRANDS INDICATE THAT THE CABLE HAD RESIDUAL MOISTURE PRESUMABLY FROM BEING PROCESSED. THIS LED TO A BREAKDOWN OF THE INSULATION. PER THE CABLE NOTES ON USE (NOU) THERE MUST BE SUFFICIENT DRYING OF THE PRODUCT AFTER REPROCESSING. ALSO, THE NOU EXPRESSLY STATES THAT THE CABLE SHOULD BE INSPECTED BEFORE USE AND NO LONGER BE USED IF IT WAS DAMAGED. ERBE IS CLOSING THE FILE ON THIS EVENT.

Description of Event or Problem · 0

IT WAS REPORTED THAT AN INCIDENT OCCURRED WITH AN ERBE BIPOLAR CABLE DURING A TRANSURETHRAL RESECTION OF BLADDER POLYPS. INFORMATION REGARDING THE ELECTROSURGICAL UNIT (ESU) USED, AND ANY OTHER ACCESSORIES INVOLVED WAS NOT PROVIDED. ALSO, THE ESU SETTINGS EMPLOYED WERE NOT CONVEYED TO ERBE. PER THE ACCOUNT THEY HEARD A "BOOM" AND THEY NOTICED THAT THE CONNECTION POINT WAS BURNT. THERE WAS NO REPORT OF ANY PATIENT OR USER INJURY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
95612	BIPOLAR CABLE; TUR/TCR; STORZ; MF PLUG, L 4M	BIPLAR CABLE	GEI	ERBE ELEKTROMEDIZIN GMBH		0321

Patients

Seq	Age	Sex	Outcome	Treatment
1