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

Model Number WA00014A

Device Problems Split (2537); Sparking (2595)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/30/2015

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report has not been returned to olympus for evaluation.The exact cause of the user's experience could not be conclusively determined.The instructions for use warn users: "visually inspect the entire hf cable.Do not use an hf cable with brittle or defective insulation.Replace the hf cable if necessary." if significant information is received or if the device is returned at a later time, this report will be supplemented accordingly.

Event Description

Olympus was informed that during a therapeutic transurethral resection of the prostate (turp) procedure, the physician was using the device when it was observed that the cord split and sparked.The device was removed and another similar device was used to complete the intended procedure.There was no patient or user injury reported.No additional information was provided.

Manufacturer Narrative

This supplemental report is being submitted to provide the device evaluation results.The device referenced in this report was returned to olympus for evaluation.The reported complaint of cord splitting was confirmed but was unable to confirm the report of cable sparking.Visual inspection found that the plug on the high frequency cable was broken.Investigation was unable to perform continuity test and other additional test due to the broken plug.The plug was dissected and it showed that the wire exhibited burn stain.Further inspection showed no evidence of physical damage to the cable or adapter.The most likely cause of the reported event is due to the operator's technique.

• Brand Name: OLYMPUS HF CABLE
• Type of Device: HF CABLE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehntrabe 61; hamburg, 22045 ; GM 22045
• Manufacturer Contact: donny shapiro ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355161
• MDR Report Key: 5335903
• MDR Text Key: 34765569
• Report Number: 2951238-2015-00580
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 02/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2015
• 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
• Device Lot Number: 14XW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/11/2016
• 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