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

Model Number	A0358
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Olympus (oci) was informed by the nurse at the user facility, the customer high-frequency monopolar cable malfunctioned, ¿the cable started to hum (auditory) and then became red and snapped in two.¿ the customer reported event was found during a laparoscopic cholecystectomy procedure.Another cable was used to complete the intended procedure.No other equipment was replaced and no death or injury and no impact to patient or other was reported to olympus.
Additional Manufacturer Narrative
The investigation is still ongoing; however, if additional information becomes available, this report will be supplemented accordingly.In general, the end-user is required to inspect the device for defects, check the function of all devices and have alternate equipment prior to use.
Additional Manufacturer Narrative
This supplemental report was submitted to provide the results of the physical evaluation and the device history records review.A review of the manufacturing and quality control review was performed for the subject device and shows no non-conformities with respect to the described problem.The device history records indicates the device was manufactured according to valid instructions and met all specifications.A visual inspection on the as received condition of the suspect device confirmed the cable was damaged and detached near the female plug end.The damaged portion shows burnt cables with char marks on the insulation of the cable.Also, signs of foreign residue was on the damaged portion.Due to the condition of the cable, no functional testing could be performed.The investigation is still ongoing; however, if additional information becomes available, this report will be supplemented accordingly.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 8 years since the subject device was manufactured.Based on the results of the investigation, the root cause of the damage is likely attributed to age-related wear associated with improper handling.The suggested events are detectable and preventable by handling the device in accordance with the instructions for use which states the service life of the cable was limited to 12 months.Olympus will continue to monitor field performance for this device.

• Brand Name: HF-CABLE, MONOPOLAR
• Common Device Name: HIGH-FREQUENCY MONOPOLAR CABLE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, de 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16368038
• Report Number: 9610773-2023-00488
• Device Sequence Number: 12447342
• Product Code: HET
• UDI-Device Identifier: 04042761001557
• UDI-Public: 04042761001557
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K944200
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/13/2023

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
• Operator of Device: Health Professional
• Device Model Number: A0358
• Device Catalogue Number: A0358
• Device Lot Number: 505619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2023
• Supplement Date Received by Manufacturer: 03/21/2023; 06/22/2023
• Initial Report FDA Received Date: 02/13/2023
• Supplement Report FDA Received Date: 04/18/2023; 07/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: VALLEY LAB GENERATOR.
• Patient Sex: Unknown