MAUDE Adverse Event Report: GYRUS ACMI, INC. PK SUPER LOOP; ENDOSCOPIC ELECTROSURGICAL HANDPIECE/ELECTRODE, BIPOLAR, SINGLE-USE

Model Number	714941
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus that the bipolar resection loop broke while being used inside the patient.The issue occurred during the therapeutic procedure (turp - transurethral resection of the prostate), there was no delay, and the procedure was completed with a similar device.The fragment fell into the device (not the patient) and there was no patient harm associated with the event.
Additional Manufacturer Narrative
The device was reportedly discarded and not expected to be returned for evaluation.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Additional Manufacturer Narrative
The initial medwatch incorrectly reported the site registration number.The site registration number is (b)(4).

• Brand Name: PK SUPER LOOP
• Common Device Name: ENDOSCOPIC ELECTROSURGICAL HANDPIECE/ELECTRODE, BIPOLAR, SINGLE-USE
• Manufacturer (Section D): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer (Section G): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16401985
• Report Number: 3005975494-2023-00028
• Device Sequence Number: 19655770
• Product Code: GEI
• UDI-Device Identifier: 00821925039551
• UDI-Public: 00821925039551
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K031085
• 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
• Report Date (Section B): 05/22/2023

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: 714941
• Device Lot Number: U2206010
• 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: 01/25/2023
• Supplement Date Received by Manufacturer: 05/01/2023
• Initial Report FDA Received Date: 02/20/2023
• Supplement Report FDA Received Date: 05/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown