MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF CABLE, BIPOLAR, 4 M, FOR ESG-400 SALINE MODE; HF RESECTION CABLE, BIPOLAR

Model Number WA00014A

Device Problem Sparking (2595)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/02/2018

Event Type  malfunction  

Manufacturer Narrative

The cable was returned to olympus for evaluation.The device evaluation confirmed the spark likely came from the cable and not the working element.A visual inspection of the cable found a small deep cut on the cable close to the straight plug that attaches to the working element.A microscope was used to inspect inside the cut area of the cable and revealed char and burn marks on the internal wiring.There was no issues observed with the right angle, straight and generator connectors.No functional testing could be performed due to the damaged internal wiring.Based on the device evaluation and similar reports related to the device the root cause is most likely attributed to improper handling, overload by application of external bending and/or stress by the user in combination with exceeded service life.The instruction manual provides warning to mitigate the risk of injury to the patient and user which states, ¿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 transurethral resection of a prostate (turp) procedure, a spark occurred near the working and cable connection.The location of the spark was unknown.The intended procedure was completed with a similar cable and working element with no issue.There was no patient / user injury reported.

• Brand Name: HF CABLE, BIPOLAR, 4 M, FOR ESG-400 SALINE MODE
• Type of Device: HF RESECTION CABLE, BIPOLAR
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355124
• MDR Report Key: 7607465
• MDR Text Key: 112283685
• Report Number: 2951238-2018-00355
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 04042761076449
• UDI-Public: 04042761076449
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/15/2018

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: 168W-4187
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/31/2018
• Initial Date FDA Received: 06/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2016
• 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