MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF CABLE; ELECTROSURGICAL CUTTING AND COAGULATION DEVICE

Model Number WA00014A

Device Problems Break (1069); Sparking (2595)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/09/2016

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report was returned to olympus for evaluation.The reported complaint confirmed that the straight plug that connects to the working element had broken off from the cord, exposing the internal electrical wiring with charred stains as signs of thermal damage.White residue was observed inside the straight plug pin.Due to the risk of injury, the damaged cable could not be tested for functionality.In addition, the blue connector's lock tabs had been broken off and not returned.It is likely that excessive force was applied to the connector while trying to unplug from the esg-400 hf generator.The lot number for the returned device indicates it was manufactured november 2012.Based on the findings, the plug damage is likely caused by reprocessing, mechanical stress, and fluid invasion when the hf current was activated.The instructions manual contains warning statements in an effort to prevent damage to the cable."visually inspect the entire hf cable.Do not use a hf cable with brittle or defective insulation.Replace the hf cable if necessary.Reprocessing and mechanical stress damages the hf cable.After the first use, the hf cable has a service life of 12 months.Dispose of the hf cable after 12 months.".

Event Description

Olympus was informed that during a therapeutic transurethral resection of the prostate (turp) procedure, the high frequency (hf) cable plug sparked and broke off the unit.The facility reported there was no error displayed while it was connected to the hf generator.The settings on the hf generator were 200 for cut and 160 for coag.There was no injury to the patient or user.The intended procedure was completed by switching to a monopolar cord.

• Brand Name: HF CABLE
• Type of Device: ELECTROSURGICAL CUTTING AND COAGULATION DEVICE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, 22045 ; GM 22045
• Manufacturer Contact: donny shapiro ; 2400 ringwood ave.; san jose, CA 95131 ; 4089355161
• MDR Report Key: 5494075
• MDR Text Key: 40129937
• Report Number: 2951238-2016-00076
• 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
• Report Date: 03/10/2016

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: WA00014A
• Device Catalogue Number: WA00014A
• Device Lot Number: 12YW-0089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2016
• Initial Date Manufacturer Received: 02/09/2016
• Initial Date FDA Received: 03/10/2016
• 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