MAUDE Adverse Event Report: KARL STORZ SE & CO. KG HOPKINS TELESCOPE 30°, 4 MM, 30 CM

Model Number	27040GP1
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the during a holep resection the reusable bipolar loop separated in the patient.According to the information received, no harm to patient, user or third occurred.The case could be completed successfully with no delay.
Additional Manufacturer Narrative
The item in question was returned to the manufacturer.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
During the examination, it was found that the cutting loop was pulled out in the distal area.The reason for this could be, for example, too high a tensile force on the loop without the hf current being activated, or on the other hand that the activation time was too long and the wire thus burned through.The ifu points out the correct handling.Since the torn wire was not sent along, it can also not be traced how often this was already in use and possibly worn out.The event is filed under internal karl storz complaint id:(b)(4).

• Brand Name: HOPKINS TELESCOPE 30°, 4 MM, 30 CM
• Common Device Name: HOPKINS TELESCOPE
• 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: 17686918
• Report Number: 9610617-2023-00232
• Device Sequence Number: 17775131
• Product Code: FAJ
• UDI-Device Identifier: 04048551093597
• UDI-Public: 4048551093597
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K943176
• 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
• Report Date (Section B): 10/20/2023

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
• Device Catalogue Number: 27040GP1
• Device Lot Number: NN51
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2023
• Supplement Date Received by Manufacturer: 10/17/2023
• Initial Report FDA Received Date: 09/05/2023
• Supplement Report FDA Received Date: 10/20/2023
• Was Device Evaluated by Manufacturer? (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
• Patient Sex: Unknown