MAUDE Adverse Event Report: KARL STORZ SE & CO. KG 27040GP1-S

Model Number	27040GP1-S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2025
Type of Reportable Event	Serious Injury
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).
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became caught by the edge of the resectoscope cannula, causing the looped wire to come apart.The resectoscope was withdrawn, the loop electrode fragment was retrieved in its entirety.The pieces of the loop electrode were examined by the circulating rn's, surgical tech and the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.

• Brand Name: 27040GP1-S
• Common Device Name: 27040GP1-S
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 21318170
• Report Number: 2020550-2025-00122
• Device Sequence Number: 8129014
• Product Code: FAS
• UDI-Device Identifier: 04048551393482
• UDI-Public: 04048551393482
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/05/2025
• Report Date (Section F): 02/05/2025

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
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/24/2025
• Event Location: Hospital
• Date Report to Manufacturer: 02/05/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/05/2025
• 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
• Patient Sex: Unknown