MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-CABLE, BIPOLAR; ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL

Model Number WA00014A

Device Problem Sparking (2595)

Patient Problem Burn(s) (1757)

Event Date 12/12/2023

Event Type  malfunction  

Event Description

The olympus representative reported on behalf of the customer, the cable from the resectoscope "sparked" and "exploded" in the consultant's hand while operating without any warning.The cable was completely severed between the right-angle connection of the cable and the grey cable.The consultant stated he was ok and had a little burn on his finger from the spark.The event occurred at the end of the procedure so the consultant was able to complete the procedure.The surgeon did not receive any injury as he had double gloves on during the procedure.A different cable was further used for another patient undergoing a standard transurethral resection of prostate (turp) with bipolar.The generator was displaying error message e006 insufficient conductivity every time they would press the pedal.They changed the generator and the problem remained the same.A 15 to 20 minute procedural delay occurred.The cable was then switched to a new one and the issue was resolved and the procedure was completed.There was no injury, no mis-diagnosis, no medical intervention.The device was inspected before use and looked fine.All cases were standard level of severity and completed.There was no reported patient injury.Related patient identifiers: (b)(6) - hf-cable, bipolar (wa00014a / sn: (b)(6)) (b)(6) - hf-cable, bipolar (wa00014a / sn: (b)(6)) (b)(6) - hf unit "esg-400" (wb91051w / (b)(6)) this medwatch is for patient identifier (b)(6).

Manufacturer Narrative

The device was not returned for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.

• Brand Name: HF-CABLE, BIPOLAR
• Type of Device: ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18461130
• MDR Text Key: 332727509
• Report Number: 9610773-2024-00105
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 04042761076449
• UDI-Public: 04042761076449
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K120418
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WA00014A
• Device Lot Number: 18XW
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: HF UNIT ESG-400 (WB91051W / (B)(6))