MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-CABLE, MONOPOLAR; HI-Q HAND INSTRUMENTS, OB/GYN USE

Model Number	A0355
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to olympus for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation, or if any additional information is provided by the user facility.
Event or Problem Description
An olympus representative reported on behalf of the customer during a therapeutic procedure hf-cable, monopolar was connected to st10 and it sparked and disconnected.The device was replaced with a similar one and the procedure was completed.There were no reports of patient or user harm associated with this event.
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 for all potential lots found no deviations that could have caused or contributed to the reported issue.As the lot number could not be specifically identified, the manufacturer date is unavailable.From the potential lots shipped to the patient the age of the cable is between 5 and 13 years.Based on the results of the investigation, the root cause could not be conclusively determined as the device was not returned for evaluation.From the available information, it is likely the reported event occurred due to age related wear in combination with improper handling by the user such as application of mechanical force, stress, bending, or pulling.The following information from the instructions for use (ifu) pertains to this event; the service life of the cable is limited to 12 months.After this time, the cable should no longer be used.Furthermore, the cable must be checked for a damage prior to each use and after reprocessing.By gently pulling on the plug (with a maximum of 20 n) the user can determine if there is pre-existing damage to the stranded copper wire of the cable.If the cable does not buckle but remains firm, the cable is most likely fine in this place.Finally, in order not to increase the service life of the cable, the cable should not be wound up with a loop diameter of less than 10 cm, and the user should pull on the connector and not on the cable when unplugging the cable.Olympus will continue to monitor field performance for this device.

• Brand Name: HF-CABLE, MONOPOLAR
• Common Device Name: HI-Q HAND INSTRUMENTS, OB/GYN USE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 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: 17650265
• Report Number: 9610773-2023-02392
• Device Sequence Number: 7371097
• Product Code: HET
• UDI-Device Identifier: 04042761001533
• UDI-Public: 04042761001533
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2023

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: A0355
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• 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: 08/01/2023
• Supplement Date Received by Manufacturer: 09/11/2023
• Initial Report FDA Received Date: 08/30/2023
• Supplement Report FDA Received Date: 09/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: ST10
• Patient Sex: Unknown