MAUDE Adverse Event Report: KARL STORZ SE & CO. KG UNIPOLAR HIGH FREQUENCY CORD, 300 CM; Resectoscope

Model Number	277KB
Medical Device Problem Codes	Material Separation (1562); Sparking (2595); Explosion (4006)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that during the procedure when resecting the prostate the diathermy lead exploded and broke in half.Lead was disconnected and taken away.No harm was caused to the patient or staff members.
Additional Manufacturer Narrative
The complained 277kb was received on aug.22, 2024 at the manufacturing site and was therefore available for investigation.The investigation has been completed on september 3, 2024.During the investigation, the following was found: the cable was found cut in half.The cable wires show residues of soot as well as corroded cable ends.Only a few strands show a typical copper color.This means, that only these few strands can provide voltage and current to the instrument.The most probable root cause is the aging of the cable and therefore normal wear and tear due to its age (>8 years).According to the corresponding ifu the cable must be checked before each use.Based on the available information and the results of the examination, there is no indication for a material-, manufacturing- or design-related failure.The root cause of the reported issue can be traced back to wear and tear.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: UNIPOLAR HIGH FREQUENCY CORD, 300 CM
• Common Device Name: Resectoscope
• 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: 20036698
• Report Number: 9610617-2024-00296
• Device Sequence Number: 11521850
• Product Code: FJL
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K232486
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/01/2026

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: 277KB
• Device Catalogue Number: 277KB
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2024
• Supplement Date Received by Manufacturer: 08/22/2024; 09/04/2026
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 09/19/2024; 10/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown