MAUDE Adverse Event Report: KARL STORZ SE & CO. KG WORKING ELEMENT, BIPOLAR

Model Number	27040EB
Medical Device Problem Codes	Temperature Problem (3022); Activation Failure (3270)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/15/2024
Type of Reportable Event	Serious Injury
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).Cross reference case: (b)(4).
Event or Problem Description
It was reported that the instrument does not work correctly, it does not cut, the working element heats up, the handles of consumables are damaged, it has already caused harm to a patient.Adverse consequences for the patient: urethral injury, diagnosis from cystoscopy, urethral injury with tearing and bleeding.The patient is out of the hospital and is under observation.The patient was given an appointment in a month to perform a cystoscopy and check the patient's progress.Cross reference is covered under medwatch: 9610617-2024-00310.
Additional Manufacturer Narrative
Additional information is provided in section b5, d9 and e1.The investigation is not completed yet.The investigation results are pending.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
Additional information was provided that the patient had to stay in the hospital for 2 more days to perform the cystoscopy.The subsequent cystoscopy had to be performed to diagnose the status of the urethra.
Additional Manufacturer Narrative
Device evaluation: since the product is in good condition and not damaged, it is concluded that the application was faulty.According to the customer's description, the sling did not work.This indicates that it was incorrectly installed.As described in the ifu, it must engage audibly, otherwise the function may be impaired.However, since the article was labeled "vitalmex.", it can be concluded that it was repaired by an external company.Furthermore, the device shows no visible damage and is in good condition.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: WORKING ELEMENT, BIPOLAR
• Common Device Name: WORKING ELEMENT, BIPOLAR
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr,-kark - storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr,-kark - storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 20191880
• Report Number: 9610617-2024-00309
• Device Sequence Number: 8070082
• Product Code: FAS
• UDI-Device Identifier: 04048551075623
• UDI-Public: 04048551075623
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/24/2024

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: 27040EB
• Device Catalogue Number: 27040EB
• Device Lot Number: PL12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2024
• Supplement Date Received by Manufacturer: 09/10/2024; 10/15/2024
• Initial Report FDA Received Date: 09/11/2024
• Supplement Report FDA Received Date: 09/26/2024; 10/24/2024
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Sex: Unknown