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 Problem Electrical Shorting (2926)

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

Event Date 11/25/2019

Event Type  malfunction  

Manufacturer Narrative

The subject device was not returned for evaluation however it was reported that the subject cable was purchased in 2016 and is more than two years old.The likely possible cause of the reported issue was due to normal wear and tear of the device.As a preventive measure, the instruction manual provides several warning statements: inspection and testing restricted service life : do not use the hf cable after one year of use.Visually inspect the cable and the plugs for irregularities on the surface.Damaged cable.Do not use a cable with brittle or defective insulation.Replace the cable.

Event Description

It was reported that during a turp (transurethral resection of the prostate) a short circuit occurred on the hf cable a0393.The cord was severed in the area of the strain relief boot on the side where the cord is connected to the generator.The nurse who was holding the cord heard a pop sound and had a slight burn on her finger.The nurse was reported to be doing well and there was no serious injury reported.The doctor completed the procedure by switching to bipolar instrument.There was no patient harm or injury due to the event.

Manufacturer Narrative

This supplemental report #1 updates the following section: d10,g4,g7,h2,h3,h4,h6 and h10.The a0393 hf-cable (lot 619209) was returned for evaluation due to "cord was severed".The user's complaint was confirmed.Visual inspection on the received condition performed and found the cable torn near the boot at the side of the male connector unit.The two parts of the cable are found separated and no missing pieces of the device are observed.The tear on the cable is uneven, indicating that the device was unplugged from the generator by pulling the cable, rather than the plug.The device functional testing was not performed on the device due to the damage cable.As stated in the ifu (instructions for use).The ifu states the following, "in order to plug or unplug the cable always pull at the plug.Never pull at the cable.".Based on the device evaluation, the likely cause of the damaged and separated cable is due to mishandling.

• 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, UES-30/-40, ERBE INTL. AND VALLEYLAB (NEW) HF-UNIT.
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• MDR Report Key: 9499868
• MDR Text Key: 189620510
• Report Number: 9610773-2019-00187
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04042761001656
• UDI-Public: 04042761001656
• Combination Product (y/n): N
• PMA/PMN Number: K944201
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 02/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• 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: 619209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1