MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-CABLE, MONOPOLAR, 4 M; HF CABLE

Model Number A0393

Device Problems Melted (1385); Sparking (2595)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/08/2019

Event Type  malfunction  

Manufacturer Narrative

As part of our investigation, olympus followed up with the user facility to obtain additional information regarding the reported event.The user facility further reported the referenced cable was not returned to olympus for evaluation as the cable was discarded by the user facility following the procedure; therefore, the exact cause of the reported event could not be determined at this time.However, based on similar reported events, the most probable cause can be attributed to improper handling, overload by application of external bending and/or tensile forces by the user in combination with exceeded service life.A dhr review was performed for the affected lot without showing any non-conformities or deviations regarding the described issue.In addition, the cable was manufactured in 2009.As a preventive measure, the instruction manual¿s inspection and testing section provides warning and caution which states: the cable has a restricted service life.- do not use the hf cable after one year of use.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.

Event Description

Olympus was informed that at the beginning of a resection within the bladder procedure, the doctor reportedly stepped on the pedal of the megadyne generator and the cable sparked and melted in half at the connection to the generator where the insulation begins.The room did not need to be evacuated because it was more of a "local" event.The procedure was prolonged by about 2 minutes while a new cord and a new set of ancillary equipment were pulled from the shelf and the intended procedure was completed.There was no injury to the patient or the user reported.

• Brand Name: HF-CABLE, MONOPOLAR, 4 M
• Type of Device: HF CABLE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355124
• MDR Report Key: 8490348
• MDR Text Key: 141351924
• Report Number: 2951238-2019-00708
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04042761001656
• UDI-Public: 04042761001656
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944201
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2019
• 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: 939433
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/08/2019
• 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