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 1 of 4.

Manufacturer Narrative

This supplemental report is being submitted to provide the device evaluation results and to update sections.The high frequency (hf) cable was returned to olympus for evaluation.The evaluation was unable to confirm the reported event.Olympus was unable to test the cable due to the received condition.The distal end of the cable plug was detached and the detached portion was not returned to olympus; however, a microscope inspection found the cable with burnt stains.No internal wires of the cable were visible.Based on the investigation findings, the root cause of the reported event could not be determined as the detached portion of the device was not returned to olympus.

• 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: 5802932
• MDR Text Key: 50127639
• Report Number: 2951238-2016-00598
• 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: 11/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/29/2016
• Initial Date FDA Received: 07/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/15/2016
• 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