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

Model Number A0393

Device Problems Smoking (1585); Sparking (2595)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/12/2016

Event Type  malfunction  

Manufacturer Narrative

The device will not be 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.Based on our investigation of this report, it was reported that the device was 5 years old and passed it's 1 year life expectancy as stated in the instruction manual.The instruction manual contains several warning and caution statements in an effort to prevent damage to the cable.¿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.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 therapeutic transurethral resection of the prostate (turp) procedure, the device sparked/smoked when the physician was performing the cut function during the resection of the bladder.No emergency fire evacuation occurred as a result of the reported event.There was no patient or user injury reported.The procedure was completed.

Manufacturer Narrative

The device was returned to olympus for evaluation.The evaluation was unable to confirm the reported device malfunction.Olympus was unable to test the device as the device was received broken apart below the connector plug; however, there were no signs of burn or charred marks found with the device.The root cause for the reported event is most likely due to excessive stress and force caused by user handling.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 or risk of damaging the cable may occur.¿.

• 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: 5679762
• MDR Text Key: 46892706
• Report Number: 2951238-2016-00461
• 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: 08/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2016
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/26/2016
• 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