MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CUTTING LOOP, BIPOLAR, 24/26 FR.

Model Number	27040GP1-S
Medical Device Problem Codes	Use of Device Problem (1670); Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer will not return the device to us, we therefore are not able to forward it 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 uh801 (bipolar high frequency cord, 400 cm) 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 tupr case on (b)(6) 2024, the bipolar cutting loop that was attached to the bipolar cable sparked/burned during the case.There was no report of patient nor user injury, and they were able to complete the case using a back-up device.
Additional Manufacturer Narrative
Changes made from the initial report: updated the udi number in section d4.Per investigation by the manufacturing site: most probable root cause: aging/ wear and tear.Due to the age of the cable (manufactured in december 2022) it can be assumed that the reuse of 20 cycles was achieved.Therefore, the electrical safety was no longer given which leads to the defective seen on the provided pictures.Most likely the socket of the cable does have some bad contact to the instrument.The high current, provided by the hf generator, leads the bad connection to spark and consequently the isolation to break.A s a result, sparks and flames can be seen by the user.The ifu calls out a check of the product before using.This seems to be done correctly and was confirmed by the hospital staff.A defect of the cable could not be detected necessarily even the check is proceeded correctly.It is more the customers responsibility to check the numbers of reuses of the cable.Therefore, the defect can be rated as wear and tear as well as user fault.This event is filed under internal complaint id (b)(4).A uh801 (bipolar high frequency cord, 400 cm) 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: CUTTING LOOP, BIPOLAR, 24/26 FR.
• Common Device Name: CUTTING LOOP, BIPOLAR
• 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: 19477863
• Report Number: 9610617-2024-00162
• Device Sequence Number: 7072003
• Product Code: FAS
• UDI-Device Identifier: 04048551393482
• UDI-Public: 04048551393482
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2024

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: 27040GP1-S
• Device Catalogue Number: 27040GP1-S
• Device Lot Number: 37HC5225
• 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: Not provided
• Supplement Date Received by Manufacturer: 08/21/2024
• Initial Report FDA Received Date: 06/06/2024
• Supplement Report FDA Received Date: 09/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UH801---BIPOLAR HIGH FREQUENCY CORD, 400 CM.
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 103 KG
• Patient Ethnicity: Hispanic