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

Model Number	26055GP1
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Explosion (4006)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	11/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported: after two brief activations, the third activation triggered a suspected explosion of the resectoscope loop, resulting in extensive burn marks inside the patient's uterine cavity.Following this malfunction, the surgeon switched to an ibs (intrauterine big shaver) system to complete the treatment, along with a subsequent dilation and curettage.Post-procedure visual inspection revealed complete disappearance of the active loop, disconnection on the return electrode side, and no signs of burning at the teflon block connecting the resectoscope loop to the handpiece.The patient is currently in stable condition and has been discharged.The depth of endometrial damage caused by this incident could not be determined.Due to the injury (extensive burn marks) to the patient's uterine cavity, this case is deemed reportable.
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not returned at the time of mdr submission.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Additional information: the investigation was conducted solely based on the customer's description and the images provided, as the product was not returned for physical inspection.The investigation included review of manufacturing records, labeling, complaint history, and analyzing information received from the customer.The following steps were taken: · review of the product change history for the affected device, including drawing and last engineering change.· verification of the manufacturing date 2021-05-15 and confirmation that all production-related quality checks were passed.· review of the ifu which includes a warning advising not to overload the device.· analysis of the information received from the customer, which showed/ described the molten-down electrode.· review of complaint history for similar events.Failure mode and analysis of information received from the customer: the documented damage characteristics including the observed thermal and surface changes, are consistent with scenarios in which the product was not handled or used in accordance with the instructions for use.The most appropriate of these scenarios is that the working electrode came into contact with the neutral electrode, creating a short circuit.This concentrated a high amount of energy at the touchpoint, leading to localized melting.However, the exact circumstances that led to this contact could not be determined retrospectively, as the relevant structures are no longer intact and the product is not available for detailed analysis.No specific failure mode or component malfunction was identified.Conclusions: the investigation did not reveal any root cause related to the device design, labeling, or manufacturing process.All quality control measures were met, and no non-conformities were found in the production records.The labeling was confirmed to contain adequate instructions and warnings.The event is therefore attributed to a user error, and no corrective actions related to the device are deemed necessary at this time.However, we will continue to track and trend complaints according to our procedures.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
The most appropriate of these scenarios is that the working electrode came into contact with the neutral electrode, creating a short circuit.This concentrated a high amount of energy at the touchpoint, leading to localized melting.The investigation did not reveal any root cause related to the device design, labeling, or manufacturing process.All quality control measures were met, and no non-conformities were found in the manufacturing records.The labeling was confirmed to contain adequate instructions and warnings.The event is therefore attributed to a user error, and no corrective actions related to the device are deemed necessary at this time.However, we will continue to track and trend complaints according to our procedures.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: CUTTING LOOP, BIPOLAR
• 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
• MDR Report Key: 23744789
• Report Number: 9610617-2025-02272
• Device Sequence Number: 8449239
• Product Code: FJL
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K221893
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/29/2026

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: 26055GP1
• Device Catalogue Number: 26055GP1
• Device Lot Number: SO02
• Was Device Available for Evaluation?: No
• 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: 11/20/2025
• Supplement Date Received by Manufacturer: 01/20/2026; 03/17/2026; 09/04/2026
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 02/17/2026; 04/13/2026; 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Disability
• Patient Sex: Unknown