MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH OLYMPUS HF CABLE

Model Number WA00014A

Device Problem Electrical Shorting (2926)

Patient Problem Shock (2072)

Event Date 08/27/2015

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report has not yet been returned to olympus for evaluation.The exact cause of the reported event could not be conclusively determined at this time.If additional information is received, this report will be supplemented.The instruction manual warns users to "visually inspect the entire hf cable.Do not use a hf cable with brittle or defective insulation.Replace the hf cable if necessary.".

Event Description

Olympus was informed that during a therapeutic transurethral resection of the prostate (turp) procedure, while cutting tissue the physician was shocked in the palm.It was reported that the physician required no medical treatment.The cord was working intermittently and it was noted that whenever the scope was maneuvered, the cord would stop working.The cord was inspected and the outside insulation appeared to be intact; however, when he bent the hard plastic on the connection piece it was observed that the wires were detached.There was a two-three minute delay that occurred while the cord was replaced.The intended procedure was completed.There was no patient injury reported.Olympus followed up with the user facility to obtain additional information regarding the reported event and was informed that it was unknown if the cord had been inspected prior to the procedure.

• Brand Name: OLYMPUS HF CABLE
• Type of Device: HF CABLE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer Contact: noemi schambach ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355002
• MDR Report Key: 5087177
• MDR Text Key: 26238618
• Report Number: 2951238-2015-00441
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120418
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: WA00014A
• Device Catalogue Number: WA00014A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1