MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CUTTING LOOP, BIPOLAR; BIPOLAR SINGLE USE CUTTING LOOP

Model Number	27040GP130-S
Medical Device Problem Codes	Material Separation (1562); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing site evaluation: complaint confirmed.The distal end has broken off.There is temperature damage to the remaining cutting loop.There is also evidence of thermal damage to the proximal end.Investigation on-going.Should relevant additional information/investigation results become available, a supplemental medwatch report will be submitted unsolicited.The ifu 97000002usca 02-2019, states " the product should not be manipulated or bent.Overloading the instrument by exerting too much force may cause the medical device to break, bend, and malfunction, and consequently injure the patient or user.Do not overload the instruments.Do not bend bent instruments back to their original positions".
Event or Problem Description
It was reported there was a malfunction with a 27040gp130-s cutting loop, bipolar 0.3mm, 24/26 fr.According to the information received "the bipolar top broke off while being used in the bladder" patient harm is not known at the date of this report.It is not known if the broken piece remained in patients body.Additional information has been requested but not yet receives as of the date of this report.
Additional Manufacturer Narrative
Manufacturing site evaluation: based on the error pattern, the cutting wire has melted through/broken at the two bends (near the insulation including meltdowns on the insulation).The most probable root cause is that the wire became too hot and was damaged as a result.The ifu points out the correct handling.Internal complaint number is (b)(4).

• Brand Name: CUTTING LOOP, BIPOLAR
• Common Device Name: BIPOLAR SINGLE USE CUTTING LOOP
• 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: ms. fair ; 2151 e. grand avenue; el segundo, CA 90245 ; 4242188247
• MDR Report Key: 17148218
• Report Number: 9610617-2023-00129
• Device Sequence Number: 5818551
• Product Code: FAS
• UDI-Device Identifier: 04048551393864
• UDI-Public: 4048551393864
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2023

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: 27040GP130-S
• Device Catalogue Number: 27040GP130-S
• Device Lot Number: XN09
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/30/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2023
• Supplement Date Received by Manufacturer: 11/30/2023
• Initial Report FDA Received Date: 06/16/2023
• Supplement Report FDA Received Date: 12/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2022
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown