MAUDE Adverse Event Report: KARL STORZ SE & CO. KG BIPOLAR BALL ELECTRODE 5 FR.

Model Number	26159GC
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	04/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.The 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 hysteroscopy, in order to cut out the endometrial polyp, the tip of electrode exploded into few pieces inside of the uterus.A micrograsper was used to evacuate some of them.Because of pressure of liquid inside of the uterus, there is a chance that some of the pieces went through the tubes into the douglas pouch.It was reported that patient has no problems after surgery.As it cannot be excluded that some pieces remained in the patient's body, the case is deemed precautionary reportable.Note: the customer did not provide the article number of the affected device.It was only reported that it was a bipolar ball electrode 5 fr.Without further information it cannot be determined which is the exact article affected and if it was even a karl storz article.
Additional Manufacturer Narrative
Additional information was added in section b5 and h6.The affected device will not be returned for investigation to the manufacturer.Should additional information / investigation results become available, a supplemental report will be submitted.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
The procedure was prolonged by more than 15 minutes but less than 60 minutes.The product was scrapped during the incident.
Additional Manufacturer Narrative
Additional information added to reflect in section b5, section d product information and g4.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
Additional information received july 23,2025: the exact prolongation of the surgery was 20 minutes.
Additional Manufacturer Narrative
As the item complained about is not available for technical examination, the cause analysis can only be based on the customer's information.The high-voltage test carried out as part of quality assurance did not reveal any abnormalities in the affected batch.This indicates that a production-related defect is unlikely.The available evidence suggests that either excessive mechanical stress on the distal end of the electrode or excessive electrical voltage - or a combination of both factors - could have led to the breakage.However, a conclusive and reliable assessment of the cause is only possible through a physical examination of the affected item.The above conducted investigations did not reaveal a root cause related to the labelling or the device history.All production related quality checks were passed and no non-conformities were identified in the devices manufacturing records.The labelling was found to contain adequate instructions and warnings.The complaint history did not reveal any pick up in similar complaints, no trend was identified.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: BIPOLAR BALL ELECTRODE 5 FR.
• Common Device Name: BIPOLAR BALL ELECTRODE 5 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: 22387231
• Report Number: 9610617-2025-01134
• Device Sequence Number: 7137828
• Product Code: GCJ
• UDI-Device Identifier: 04048551094327
• UDI-Public: 04048551094327
• Combination Product (Y/N): N
• Initial Reporter Country: LO
• PMA/510(K) Number: K951986
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/30/2025

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: 26159GC
• Device Catalogue Number: 26159GC
• Device Lot Number: UP03
• 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: 07/01/2025
• Supplement Date Received by Manufacturer: 07/10/2025; 07/15/2025; 10/29/2025
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 07/11/2025; 08/06/2025; 10/30/2025
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown