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

Model Number	27040GP1-S
Medical Device Problem Codes	Material Fragmentation (1261); Material Frayed (1262); Arcing of Electrodes (2289); Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product requested but not yet received.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.The malfunction is filed under internal complaint id (b)(4).
Event or Problem Description
According to the information received during the case, using the resectoscope during hysteroscopy, the bipolar cutting loop started to fray, melt, and created a spark.No change to patients' status and didn't cause any further complications during the case.
Additional Manufacturer Narrative
Per the salesrep, product will not be returned for evaluation.Product was thrown out.

• Brand Name: BIPOLAR ELECTRODE 24/26 FR
• Common Device Name: CUTTING LOOP
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, gm, ; GM
• Manufacturer (Section G): KARL STORZ SE & CO.KG; dr.-karl-storz -strasse 34; 78532; tuttlingen, gm, ; GM
• Manufacturer Contact: anja fair ; 2151 e. grand avenue; el segundo, CA
• MDR Report Key: 16022330
• Report Number: 9610617-2022-00331
• Device Sequence Number: 5884113
• Product Code: FAS
• UDI-Device Identifier: 04048551393482
• UDI-Public: 4048551393482
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2023

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-S
• Device Catalogue Number: 27040GP1-S
• 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: 11/21/2022
• Supplement Date Received by Manufacturer: 01/06/2023
• Initial Report FDA Received Date: 12/21/2022
• Supplement Report FDA Received Date: 02/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female