MAUDE Adverse Event Report: KARL STORZ SE & CO. KG BIPOLAR CUTTING LOOP; CUTTING LOOP 24/26 BIPOLAR

Model Number	27040GP140-S
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was event with 27040gp140-s cutting loop, bipolar 24/26 fr.According to the information received via medwatch report (b)(4): the surgeon was performing a transurethral resection of the prostate (turp) and used the storz bipolar cutting loop, (diameter 0.40mm).The product was defective.The top prongs on the device came off in the patient's urethra.The surgeon was able to remove the pieces and applied a 22 fr 3 way foley catheter for hematuria.Patient harm was not noted at time of this report as the catheter was inserted for prevention.Additional information has been requested but not yet received as of the date of this report.
Additional Manufacturer Narrative
The product was discarded by accident per the sales representative, therefore, no evaluation has been completed.Investigation on-going.Should relevant additional information/investigation results become available, a supplemental medwatch report will be submitted unsolicited.The event is filed under internal karl storz complaint id (b)(4).
Additional Manufacturer Narrative
Per manufactures findings: based on the customer's description, part of the loop wire at the distal end has come out and has fallen into the patient.This can happen, for example, if the sling is pulled with too high a tensile force in the application.Since the article is not available/sent in for examination, no precise statement can be made.An excessive force effect would be due to the customer.The event is filed under internal karl storz complaint id (b)(4).

• Brand Name: BIPOLAR CUTTING LOOP
• Common Device Name: CUTTING LOOP 24/26 BIPOLAR
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, gm, ; GM
• Manufacturer (Section G): KARL STORZ SE & CO.KG; dr.-karl-storz -strasse 34; 78532; tuttlingen, gm, ; GM
• Manufacturer Contact: anja fair ; 2151 e. grand avenue; el segundo, CA 90245 ; 4242188247
• MDR Report Key: 16335626
• Report Number: 9610617-2023-00030
• Device Sequence Number: 6817837
• Product Code: FAS
• UDI-Device Identifier: 04048551393208
• UDI-Public: 4048551393208
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K061541
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2023

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: 27040GP140-S
• Device Catalogue Number: 27040GP140-S
• Device Lot Number: 37HB9087
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2023
• Supplement Date Received by Manufacturer: 06/15/2023
• Initial Report FDA Received Date: 02/09/2023
• Supplement Report FDA Received Date: 08/10/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male