MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CUTTING LOOP, BIPOLAR, 0.30MM, 24/26 FR.

Model Number	27040GP130-S
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The previous reportability decision for this event was reversed based on a retrospective review.The affected device has been requested for investigation by the manufacturer.Device was not returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that loop broke off during procedure.No patient impact.

• Brand Name: CUTTING LOOP, BIPOLAR, 0.30MM, 24/26 FR.
• Common Device Name: CUTTING LOOP, BIPOLAR, 0.30MM, 24/26 FR.
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: christiane klaiber ; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 17421321
• Report Number: 9610617-2023-00195
• Device Sequence Number: 9025017
• Product Code: FAS
• UDI-Device Identifier: 04048551393864
• UDI-Public: 4048551393864
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/28/2023

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: 27040GP130-S
• Device Catalogue Number: 27040GP130-S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2023
• Initial Report FDA Received Date: 07/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown