MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CUTTING LOOP BIPOLAR 27/28FR.; BIPOLAR SINGLE USE ELECTRODE

Model Number	27040GPB1-S
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is a single use electrode.The electrode was retained by the facility and therefore, no evaluation can be done.
Event or Problem Description
Allegedly per the customer, during a urology procedure, the entire loop disengaged from the working element and came out of the sheath inside the patient.The broken part of the electrode was safely removed with no harm to the patient.The electrode was replaced and the procedure completed.

• Brand Name: CUTTING LOOP BIPOLAR 27/28FR.
• Common Device Name: BIPOLAR SINGLE USE ELECTRODE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, gm,
• MDR Report Key: 9920618
• Report Number: 9610617-2020-00044
• Device Sequence Number: 11577541
• Product Code: FAS
• UDI-Device Identifier: 04048551393529
• UDI-Public: 4048551393529
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K061541
• 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,Followup
• Report Date (Section B): 04/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 27040GPB1-S
• Device Catalogue Number: 27040GPB1-S
• Device Lot Number: 37KI1211
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/05/2020
• Supplement Date Received by Manufacturer: 03/05/2020
• Initial Report FDA Received Date: 04/03/2020
• Supplement Report FDA Received Date: 04/16/2020
• 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: Required Intervention