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

Model Number	26040JB1
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device has not been returned to the manufacturer.No further details of the event are available.
Event or Problem Description
As per an aer received from (b)(6) by the factory in (b)(4), involving a bipolar cutting loop: break inside the uterus.

• Brand Name: ELECTRODE, CUTTING, BIPOLAR, STERILE, 24/26FR
• Common Device Name: BIPOLAR CUTTING LOOP
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• MDR Report Key: 10175273
• Report Number: 9610617-2020-00074
• Device Sequence Number: 11403270
• Product Code: HIN
• UDI-Device Identifier: 04048551393161
• UDI-Public: 4048551393161
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K122983
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/26/2020

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: 26040JB1
• Device Catalogue Number: 26040JB1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2020
• Initial Report FDA Received Date: 06/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other