MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH SHAFT "HIQ+", 5 X 330 MM; SURG, NON-EN

Model Number	A60800A
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to olympus that on may 2nd during a surgery, sparks were emitted from the sheath when high-frequency output was generated from the laparoscopic forceps (hiq plius).The clinical engineer checked the condition of the sheath after the surgery and found that there were places where the metal under the insulating coating was exposed.There was no patient injury or adverse event reported to olympus.
Additional Manufacturer Narrative
The device was returned to olympus for evaluation and repair.The investigation is still in progress; therefore, the root cause of the reported defect cannot be determined at this time.However, if additional information becomes available, this report will be supplemented accordingly.In general, the customer is required to inspect the device for defects, check the function of all devices and have alternate equipment prior to use.Olympus will continue to monitor the field performance of this device.Additional pma/510(k): k944201.
Additional Manufacturer Narrative
Updated fields: h6, h10.Corrected fields: b5 (inadvertently missed), g2 (added selection), h10.Correction to h10: the device was not returned to olympus for evaluation and repair.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.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 use error or wear and tear.The halar coating used for insulating the shaft had probably hardened due to frequent usage and reprocessing, which led to the insulation loosening at individual spots.Therefore, it is likely the customer did not check the tube shaft properly before use per the instructions for use (ifu) and used a damaged or worn instrument.It was also noted that the product is designed for 400x reprocessing cycles.The expected service life has likely been exceeded considering the shaft¿s date of manufacture.Olympus will continue to monitor field performance for this device.
Event or Problem Description
The procedure was a therapeutic laparoscopic surgery.

• Brand Name: SHAFT "HIQ+", 5 X 330 MM
• Common Device Name: SURG, NON-EN
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, de 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, de
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16986978
• Report Number: 9610773-2023-01400
• Device Sequence Number: 17875531
• Product Code: HET
• UDI-Device Identifier: 04042761009843
• UDI-Public: 04042761009843
• 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
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2023

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: A60800A
• Device Catalogue Number: A60800A
• Device Lot Number: 06XW-0787
• 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: 05/02/2023
• Supplement Date Received by Manufacturer: 09/01/2023
• Initial Report FDA Received Date: 05/23/2023
• Supplement Report FDA Received Date: 09/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2006
• 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
• Patient Sex: Unknown