MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-CABLE, MONOPOLAR, 4 M, UES-30/-40,; HF CABLE

Model Number A0393

Device Problem Sparking (2595)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/20/2016

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to olympus for evaluation.The cause of the reported event could not be determined; however, user handling could not be ruled out as a contributing factor.The instruction manual contains several warning statements in an effort to prevent damage to the cable.¿visually inspect the cable and the plugs for irregularities on the surface.Do not use a cable with brittle or defective insulation.Replace the cable.In order to plug or unplug the cable always pull at the plug.Never pull at the cable.¿.

Event Description

Olympus was informed that during a transurethral resection of the prostate (turp) procedure, the high frequency (hf) cable sparked and smoked.There was no injury to the user or patient.No emergency fire evacuation took place.The procedure was completed using a different hf cable.This is report 2 of 4.

Manufacturer Narrative

The high frequency (hf) cable was returned to olympus for evaluation.The evaluation confirmed that the hf cable broken into two pieces and found detached.The hf cable could not be tested due to its received condition; however, a microscopic inspection was performed on the returned cable and found charred stains inside the internal wires of the distal end plug, which is the part that was connected to the working element.There were white residues noted on the cable insulation housing from the proximal end plug.Based on the investigation findings, it was determined that the most likely cause of the reported event is a short on the internal wires of the cable.

• Brand Name: HF-CABLE, MONOPOLAR, 4 M, UES-30/-40,
• Type of Device: HF CABLE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg
• Manufacturer Contact: donny shapiro ; 2400 ringwood avenue; san jose, CA 95131 ; 408935-516
• MDR Report Key: 5802942
• MDR Text Key: 49957910
• Report Number: 2951238-2016-00600
• Device Sequence Number: 1
• Product Code: DSA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK944201
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2016
• 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: 342998
• Other Device ID Number: 04042761001656
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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