MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-CABLE, MONOPOLAR, 4 M, UES-30/-40, ERBE INTL. AND VALLEYLAB (NEW) HF-UNIT.

Model Number A0393

Device Problems Fire (1245); Sparking (2595)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/30/2019

Event Type  malfunction  

Manufacturer Narrative

The referenced device was not returned for evaluation.The cause of the reported complaint cannot be confirmed.As preventive measures, the cable instructions states ¿do not use the hf cable after one year of use.¿visually inspect the cable and the plugs for irregularities on the surface.And do not use a cable with brittle or defective insulation.Replace the cable.¿.

Event Description

The service center was informed that during an unspecified therapeutic transurethral resection of the prostate (turp) procedure, when the hf cable sparked with a small fire and broke off at the black connection attached to the non-olympus generator.The intended procedure was completed using a similar cable.There was no patient injury reported.

• Brand Name: HF-CABLE, MONOPOLAR, 4 M, UES-30/-40, ERBE INTL. AND VALLEYLAB (NEW) HF-UNIT.
• Type of Device: HF-CABLE, MONOPOLAR, 4 M,
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662
• MDR Report Key: 9244332
• MDR Text Key: 163926466
• Report Number: 9610773-2019-00149
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04042761001656
• UDI-Public: 04042761001656
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944201
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A0393
• Device Catalogue Number: A0393
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/02/2019
• 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