MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-CABLE, BIPOLAR, 4 M, TURIS/TCRIS RESECTOSC; ELECTROSURGICAL RESECTION AND VAPORIZATION

Model Number WA00014A

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/18/2016

Event Type  malfunction  

Manufacturer Narrative

The hf-cable was not returned to olympus for evaluation.The cause of the reported event cannot be determined; however, the most likely cause of the reported event can be attributed to user handling or the use of the cable after the manufacture¿s recommended service of life period.The instruction manual warns users ¿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 resection procedure, the surgical staff heard a pop sound and the i shape (connection point) of the hf-cord split in two as it disconnected from the working element.The procedure was completed using a similar device.There was no patient injury reported.

Manufacturer Narrative

The device was returned to olympus for evaluation.A visual inspection was performed on the received device and found the straight plug that connects to the working element equipment broken off from the cord, exposing the internal electrical wires and the cable insulation was observed to be slightly melted with evidence of thermal damage.In addition, there was evidence of wear on the hf plug as a gap was found between the hf connector boot and the blue plug.Due to the returned condition of the cable no further testing could be performed.Based on the investigation findings and similar reported events, the reprocessing, mechanical stress due to mishandling, and moisture invasion could have attributed to hf cable damage; resulting in the internal wiring becoming broke as the hf current was activated.

• Brand Name: HF-CABLE, BIPOLAR, 4 M, TURIS/TCRIS RESECTOSC
• Type of Device: ELECTROSURGICAL RESECTION AND VAPORIZATION
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 408935-512
• MDR Report Key: 6172587
• MDR Text Key: 62381456
• Report Number: 2951238-2016-00942
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK120418
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/03/2017

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: 13XW-0026
• Other Device ID Number: 04042761076449
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/22/2016
• Initial Date FDA Received: 12/13/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/03/2017
• 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