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

Model Number	27050E
Medical Device Problem Codes	Sparking (2595); Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will be forwarded to the manufacturing site for investigation.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.This event is filed under internal complaint id (b)(4).A 277kb unipolar high frequency cord was used together with this device during the incident as a concomitant item (as listed in section d10), which was filed under another internal complaint id (b)(4).
Event or Problem Description
It was reported that during a transurethral resection of bladder tumor procedure on (b)(6) 2024, something caused a spark when using the monopolar cable and working element.There was no patient nor user harm reported, and they were able to complete the procedure using a back-up device, this caused a delay of about 15 minutes.
Additional Manufacturer Narrative
Changes made from the initial report: updated the udi number in section d4.Per investigation by the manufacturing site: the cause of the error can be traced back to the user.A bulge can be seen in the white teflon block, this was caused by thermal development inside.The thermal development can be caused, for example, by a short circuit, flashover, etc.Possible causes include residual moisture inside the instrument.Moisture also explains the corrosion on the surface of the instrument.This event is filed under internal complaint id: (b)(4).A 277kb unipolar high frequency cord was used together with this device during the incident as a concomitant item (as listed in section d10), which was filed under another internal complaint id: (b)(4).

• Brand Name: WORKING ELEMENT
• Common Device Name: WORKING ELEMENT
• 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 ; 4242188247
• MDR Report Key: 19697787
• Report Number: 9610617-2024-00201
• Device Sequence Number: 3701374
• Product Code: HIH
• UDI-Device Identifier: 04048551077542
• UDI-Public: 04048551077542
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K882270
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2024

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: 27050E
• Device Catalogue Number: 27050E
• Device Lot Number: ZU11
• 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: 06/11/2024
• Supplement Date Received by Manufacturer: 08/14/2024
• Initial Report FDA Received Date: 07/08/2024
• Supplement Report FDA Received Date: 08/28/2024
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 277KB---UNIPOLAR HIGH FREQUENCY CORD, 300 CM.
• Patient Age: 86 YR
• Patient Sex: Female
• Patient Weight: 62 KG