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

Model Number	27040GP1-S
Medical Device Problem Codes	Break (1069); Arcing (2583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient was in for transurethral bladder tumor resection.In the commission of the planned procedure on (b)(6) 2025, a resectoscope loop electrode became caught by the edge of the resectoscope cannula, causing the looped wire to come apart.The resectoscope was withdrawn, the loop electrode fragment was retrieved in its entirety.The pieces of the loop electrode were examined by the circulating rn's, surgical tech and the surgeon and all agreed that the electrode was removed from the patient completely.The surgeon completed a review of the bladder cystoscopically and found no retained pieces.All related equipment (the resectoscope, the iglesias working element and the resectoscope electrode) were reviewed preoperatively with no defects noted preoperatively.Resectoscopic electrode accidently pulled apart upon removal from the resectoscopic cannula, all pieces removed.Patient examined immediately after retrieval of the broken electrode by surgeon using videoscopic cystoscope and no injury was found.The electrode was replaced, and the procedure was completed without further incident.
Additional Manufacturer Narrative
The device in question is not expected to be returned.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
Correction in section d1 brand name and d2 common device name.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Additional information: the device was not sent to the manufacturer for inspection.A technical inspection by the manufacturer could not be carried out and therefore the fault description "looped wire came appart" provided by the customer could not be confirmed.The description suggests that the sling bent during use.This can happen, for example, when tensile/compressive forces act on the sling without it being in operation.The forces generated in this process can cause the sling wire to break.It is not possible to determine from the description whether only the cutting edge has broken or whether the entire wire has detached from the deformation.Based on the available information, the error description, and similar complaints, user error can therefore be concluded.The above investigations did not reveal a root cause related to the labelling, the device, or its history.All production-related quality checks were passed, and no non-conformities were identified in the device's manufacturing records.The labelling was found to contain adequate instructions and warnings.The complaint history did not reveal any pickup in similar complaints; no trend was identified.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: CUTTING LOOP, BIPOLAR, 24/26 FR
• Common Device Name: CUTTING LOOP, BIPOLAR, 24/26 FR
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 21318168
• Report Number: 9610617-2025-00122
• Device Sequence Number: 18174971
• Product Code: FAS
• UDI-Device Identifier: 04048551393482
• UDI-Public: 04048551393482
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K221893
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/10/2026

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: 27040GP1-S
• Device Catalogue Number: 27040GP1-S
• Device Lot Number: 37CD5843
• 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: 01/24/2025
• Supplement Date Received by Manufacturer: 02/21/2025; 02/06/2026
• Initial Report FDA Received Date: 02/05/2025
• Supplement Report FDA Received Date: 02/21/2025; 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• 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