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

Model Number	27040GP1
Medical Device Problem Codes	Break (1069); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was not returned for investigation.No available result yet.
Event or Problem Description
As per a manufacturer incident report we received from the factory in (b)(6): on (b)(6) 2021, during a surgical intervention, the bipolar resection loop again separated at the level of the yellow fixation systems.The material is lost between the bladder and the urethra with risks of perforation.
Additional Manufacturer Narrative
Upon investigation, it could be confirmed that the loop was bent.Also, at the breaking point of the loop, it can be seen that the wire has melted; this could potentially have been caused by a short circuit when the electrode came too close to the neutral electrode during use.The root cause is most likely due to mechanical overload, i.E.User error.No indication for material or manufacture defect found during investigation.Ifu already included a warning that a mechanical overload can provoke a potential risk for the patient.

• Brand Name: CUTTING LOOP, BIPOLAR, 24/26 FR.
• Common Device Name: BIPOLAR CUTTING LOOP
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• MDR Report Key: 11863538
• Report Number: 9610617-2021-00045
• Device Sequence Number: 3193956
• Product Code: FAS
• UDI-Device Identifier: 04048551393482
• UDI-Public: 4048551393482
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2021

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: 27040GP1
• Device Catalogue Number: 27040GP1
• Device Lot Number: SP38
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/23/2021
• Supplement Date Received by Manufacturer: 04/23/2021
• Initial Report FDA Received Date: 05/21/2021
• Supplement Report FDA Received Date: 07/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Disability