MAUDE Adverse Event Report: GYRUS ACMI, INC. CUTTING LOOP (12/PK); ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL

Model Number	MLE-28-012
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reports two similar events: during a transurethral resection of the prostate (turp) using a cutting loop, the cutting loop wire became dislodged from the shaft of electrode (inside the patient).The surgeon used irrigation to flush the loop out of the patient.The loop did not come into contact with any other instruments to the surgeons¿ knowledge.No further consequences to this patient have been reported.Case with patient identifier (b)(4) reports the first event using a single use cutting loop.Case with patient identifier (b)(4) reports the second event using a single use cutting loop.
Additional Manufacturer Narrative
The device referenced in this report has been returned to olympus for evaluation.The evaluation has not yet been concluded.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.
Additional Manufacturer Narrative
This report is being updated to provide investigation findings.New information is reported in h6 and h10.The device history record (dhr)s for this product have been reviewed.All records indicate that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.A total of 27 units were produced under this lot number with no associated ncrs, reported scrap or recorded process deviations relating to the reported failure.Visual inspection as received condition found the cutting loop melted and broke off on one side, but still attached on the other end.Also, there are charred marks and melted on the insulation tubes due to thermal damage.However, the blue shaft is straight, and its proximal end is intact.Also, the electrode passed the continuity when checked from both ends of wires to proximal end of shaft.Since the cutting loop was damaged, the electrode will not be checked for energy output.The observed failure is a known phenomenon likely resulting from putting the distal end through excessive stress possibly resulting in physical damage.On page 2 of the device instructions for use (ifu) shipped with the device, the user is provided with the following information relevant to this event: "keep the distal tip of any electrode or cutting loop in the field of view at all times." olympus will continue to monitor the field performance of this device.

• Brand Name: CUTTING LOOP (12/PK)
• Common Device Name: ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
• Manufacturer (Section D): GYRUS ACMI, INC.; 800 west park drive; westborough MA 01581
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 15210530
• Report Number: 3003790304-2022-00158
• Device Sequence Number: 4577450
• Product Code: FAS
• UDI-Device Identifier: 00821925038486
• UDI-Public: 00821925038486
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K890328
• 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,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2022

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 Model Number: MLE-28-012
• Device Lot Number: KR107887
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2022
• Supplement Date Received by Manufacturer: 09/14/2022
• Initial Report FDA Received Date: 08/11/2022
• Supplement Report FDA Received Date: 10/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Other
• Patient Sex: Unknown