MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-CABLE, MONOPOLAR, 4 M, UES-30/-40, ERBE INTL. AND VALLEYLAB (NEW) HF-UNIT.

Model Number A0393

Device Problem Thermal Decomposition of Device (1071)

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

Event Date 11/05/2018

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to olympus for evaluation.The exact cause of the reported event could not be determined, however, based on similar reported device complaints improper maintenance could not be ruled out as a contributing factor as the instruction manual contains several warning statements in an effort to prevent damage to the cable.¿visually inspect the cable and the plugs for irregularities on the surface.Do not use a cable with brittle or defective insulation.Replace the cable.In order to plug or unplug the cable, always pull at the plug.Never pull at the cable or risk of damaging the cable may occur.Also, when used as intended this product is more or less subject to wear depending on the intensity of use.Do not use the hf cable after one year of use.¿.

Event Description

Olympus was informed that during a therapeutic gynecological ablation resection procedure, the hf-cable sparked and then blew apart at the connection site.There was smoke noted; however, no flames were observed and the operating room was not evacuated.The non-olympus generator settings were 80 cut/80 coag with no alerts or alarms observed.Intended procedure was completed with a similar device.There was no patient injury reported.Additionally, the device was inspected prior to the procedure with anomalies noted.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information from the original equipment manufacturer.The oem performed a manufacturing and quality control review for the affected lot or serial number without showing any non-conformities or deviations regarding the described issue.

Manufacturer Narrative

This supplemental report is being submitted to report the device evaluation results.A visual inspection on the returned device found the cord completely detached from the plug that connects to the hf generator unit.Visual inspection of the damage area under a microscope reveals traces of burnt, charring deposit on the internal wirings and insulation as signs of thermal damage.Due to the damaged cable, it could not be tested for the functionality.Based on the investigation findings and similar reported events, the reprocessing, moisture invasion, or mechanical stress due to cable being pulled that could have damaged the internal wirings of the hf cable; so when the hf current was activated, the internal wirings became burst and broke.Note the hf cable should be disposed of after 12 months of use and thoroughly inspect the product for traces of wear before use.

• Brand Name: HF-CABLE, MONOPOLAR, 4 M, UES-30/-40, ERBE INTL. AND VALLEYLAB (NEW) HF-UNIT.
• Type of Device: HF-CABLE, MONOPOLAR
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355124
• MDR Report Key: 8104483
• MDR Text Key: 129353325
• Report Number: 2951238-2018-00723
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04042761001656
• UDI-Public: 04042761001656
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K944201
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 05/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A0393
• Device Catalogue Number: A0393
• Device Lot Number: 422423
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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