MAUDE Adverse Event Report: KARL STORZ SE & CO.KG BIPOLAR CUTTING LOOP

Model Number	26040GP1
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Fibrosis (3167)
Date of Event	11/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The electrode has not been returned, therefore; the product could not be evaluated.
Event or Problem Description
Allegedly, during a hysteroscopic myomectomy procedure, 2-3 mm of the bipolar electrode loop broke due to the resistance of the large fibroma.No additional information has been provided regarding the outcome to the patient.

• Brand Name: BIPOLAR CUTTING LOOP
• 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: 10317093
• Report Number: 9610617-2020-00084
• Device Sequence Number: 3542550
• Product Code: HIN
• UDI-Device Identifier: 04048551392720
• UDI-Public: 4048551392720
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K122983
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/23/2020

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: 26040GP1
• Device Catalogue Number: 26040GP1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 33 YR