MAUDE Adverse Event Report: GYRUS ACMI, INC. PK SUPER LOOP; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	714941
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that when using a pk super loop, the head of the resection loop fell into the bladder.An endoscope was used to search for the loop, but it was not found.The therapeutic procedure (transurethral resection of the prostate) was completed with a similar device.There was a procedural delay of about 30 minutes.The patient was discharged home with no adverse reactions.
Additional Manufacturer Narrative
The device was not 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 subject device was manufactured in september 2022, but the specific date is unknown.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, a specific root cause the head of the resection loop had fallen into the bladder, and wasn't retrieved could not be determined with the information received.Olympus will continue to monitor field performance for this device.

• Brand Name: PK SUPER LOOP
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• 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: 18350547
• Report Number: 3011050570-2023-00222
• Device Sequence Number: 12097714
• Product Code: GEI
• UDI-Device Identifier: 00821925039551
• UDI-Public: 00821925039551
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: 714941
• Device Lot Number: U2208040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2023
• Supplement Date Received by Manufacturer: 01/10/2024
• Initial Report FDA Received Date: 12/18/2023
• Supplement Report FDA Received Date: 01/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2022
• 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: Unknown