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

Model Number WA00014A

Device Problems Melted (1385); Sparking (2595); Non Reproducible Results (4029)

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

Event Date 08/30/2018

Event Type  malfunction  

Manufacturer Narrative

The hf cable was not returned to olympus for evaluation.The cause of the reported event could not be confirmed at this time.However, based on similar reports related to the device, the most probably cause of the reported event could be attributed to improper handling, overload by application of external bending and/or unintended stress by the user in combination with exceeded service life.The instructional manual provides warning to mitigate the risk of injury to the patient and or 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.¿ if the device is returned at a late date, this report will be supplemented accordingly.Additionally, the oem conducted a dhr review for the reported lot number.Manufacturing and quality control reviews were performed which did not show "without showing" any non-conformities or deviations during the production process.

Event Description

Olympus was informed that during a transurethral resection of a bladder tumor, the user facility reported sparks and smoke from the bipolar hf cable.The hf cable melted onto the end piece where it plugs into the working element and cannot be removed.The procedure was not delayed.The referenced equipment was replaced and the intended procedure was completed using a monopolar resectoscope set.There was no bleeding to the patient.The patient did not require a longer stay or additional treatment.Both hf cable and working element were inspected prior to the procedure and looked normal.The settings on the esg-400 generator was believed to be 200cut/120coag.No patient injury was reported.

Manufacturer Narrative

This report has been updated in the following fields: d10, g4, g7, h2, h3, h6 and h10.A wa00014a hf cable lot #168w-4483 was returned for evaluation.A visual inspection of the received condition was performed on the device; no physical anomalies observed on the wa00014a hf cable.Connectors are not melted and are in good condition.No breaks, opens or tears noted on the cable.The wa00014a hf cable was tested along with the customers wb91051w esg-400 generator (etq# c18161164) and wa22367a working element.The manufacturers wa22302d electrode was used for testing.The esg-400 was able to recognize the wa00014a hf cable.Output was observed at the distal end when activated.A continuity test was performed and the wa00014a hf cable tested and passed the continuity test.The wa00014a hf cable tested as working and fully functional.Based on the evaluation, the reported complaint was not confirmed.No physical anomalies observed on the connectors or the wa00014a hf cable.

• Brand Name: HF CABLE, BIPOLAR, 4 M, FOR ESG-400 SALINE MODE
• Type of Device: ELECTROSURGICAL RESECTION AND VAPORIZATION
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 7887637
• MDR Text Key: 120900312
• Report Number: 2951238-2018-00553
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 04042761076449
• UDI-Public: 04042761076449
• Combination Product (y/n): N
• PMA/PMN Number: K120418
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/03/2020

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
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/31/2018
• Initial Date FDA Received: 09/18/2018
• Supplement Dates Manufacturer Received: 09/14/2018
• Supplement Dates FDA Received: 01/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1