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 11/21/2016

Event Type  malfunction  

Manufacturer Narrative

As part of our investigation of this report, olympus followed up with the user facility to obtain additional information.The user facility reported that fluid from the procedure made contact with the outer portion of the cable; however, there was no fluid that came in contact near the contact points.The device will not be returned to olympus for evaluation.The cause of the reported event could not be determined; however, user handling likely contributed to the reported event as fluid invasion was found on the outer portion of the cable.

Event Description

Olympus was informed that during a therapeutic bipolar resection, a loud ¿snapping¿ sound was heard then the bipolar cautery cord blew off from the working element.No fire or fire emergency occurred.There was no patient or user injury reported.The procedure was completed using a different bipolar cautery cord.

Manufacturer Narrative

The high frequency (hf) cable was returned to olympus for evaluation.The evaluation confirmed the reported device damage.A visual inspection of the hf cable noted that the angle plug that connects to the working element was found broken off from the cord, exposing the internal electrical wirings.The cable insulation was also found slightly melted as signs of thermal damage was noted.In addition, a gap was found in between the connector boot and the blue plug of the cable.There were also traces of burnt marks and residues found on the cable insulator.Due to the condition of the damaged cable, it could not be tested for functionality.Based on the investigation findings and similar reported events, reprocessing of the cable, mechanical stress, and fluid invasion likely contributed to the reported event.The instruction manual for use states, ¿visually inspect the entire hf cable.Do not use a hf cable with brittle or defective insulation.Replace the hf cable if necessary.Improper reprocessing can cause infection of the patient and/or medical personnel.Reprocess the hf cable before first and each subsequent use following the instructions in this instruction manual and in the ¿olympus endoscopy system guide¿.The lot number allows the user to keep track of the hf cable.This lot number can help to record reprocessing cycles or the service life of each hf cable.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.¿.

• 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: 6172569
• MDR Text Key: 62386444
• Report Number: 2951238-2016-00939
• 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,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/07/2017

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
• Other Device ID Number: 04042761076449
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/21/2016
• Initial Date FDA Received: 12/13/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/07/2017
• 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