MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, MEDIUM, 24 FR., 12°-30°, ESG TCRIS; ENDOSCOPIC ELECTROSURGICAL UNIT AND ACCESSORIES

Model Number	WA47706S
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported to olympus the hf-resection electrode "plasmaloop" was missing after being used in a patient during a hysteroscopy with fibroid resection.The loop was there when inserting device and when removing, the loop was missing.It was stated that the loop broke inside the patient and was not retrievable, and it potentially was retained by the patient.An x-ray after the procedure and a thorough examination of the uterus was done, but they were unable to visualize or locate the missing portion.It was stated that the procedure was unable to be completed.Additional follow up was requested.
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.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation and updates to b5, d4, d9, h3, and h6.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device was returned to olympus for inspection, and the reportable malfunction was confirmed.The exact root cause of the reported phenomenon could not be conclusively determined.It has been concluded that the possible cause of the event was likely due wear and tear.Despite the noticeable interruption of the loop wire, the user continued to resect tissue until the wire had burned down completely.To mitigate the risk of device malfunction and patient/user injury, the instruction manual contains the following description related to this reported phenomenon: caution 1: "caution risk of injury to the patient contact between the hf-resection electrode and metal parts, such as other endoscopic equipment, implants or stents can result in sparkover between the hf-resection electrode and the metal part.Always keep a distance of at least 10 mm between the hf-resection electrode and metal parts." caution 2: "caution risk of injury to the patient use extreme caution when using electrosurgery in close proximity to or in direct contact with any metal objects.Do not activate the hf-resection electrode while any portion of the hf-resection electrode tip is in contact with another metal object.This can cause uncontrolled heating of the hf-resection electrode and may result in damage and breakage to the hf-resection electrode tip.If excessive heating or physical forces cause damage to the hf-resection electrode tip, broken device fragments may remain in the body, possibly requiring additional surgery for removal." olympus will continue to monitor field performance for this device.
Event or Problem Description
Additional information stated that the patient was discharged as planned, and there was no extension of their hospital stay.It was noted that the device was inspected prior to use.

• Brand Name: HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, MEDIUM, 24 FR., 12°-30°, ESG TCRIS
• Common Device Name: ENDOSCOPIC ELECTROSURGICAL UNIT AND ACCESSORIES
• 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: 17699301
• Report Number: 9610773-2023-02484
• Device Sequence Number: 17991971
• Product Code: FAS
• UDI-Device Identifier: 14042761085530
• UDI-Public: 14042761085530
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K171965
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/03/2025
• Device Model Number: WA47706S
• Device Lot Number: 1100410974
• 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: 08/10/2023
• Supplement Date Received by Manufacturer: 08/30/2024
• Initial Report FDA Received Date: 09/07/2023
• Supplement Report FDA Received Date: 09/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female