MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ELECTRODE,CUTTING,STERILE.24FR; MONOPOLAR SINGLE USE CUTTING LOOP

Model Number	27050G-S
Medical Device Problem Codes	Energy Output Problem (1431); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer's complaint reference number for this case is (b)(4) which reports all incidents in one case.Three related complaints to this event (b)(4), (b)(4) and (b)(4).In a case on (b)(6) 2022 with dr.(b)(6), per the staff in the room, 4 loops out of the same box broke right in the middle of the loop every time (this was true for all of them).No harm reported to patient.
Additional Manufacturer Narrative
All 3 of the electrodes sent in have the same evaluation findings.The distal loop is broken.The ends of the remaining loop are burnt.The yellow insulation has melted and there is black residue.At the proximal end of the piece, the black coating has separated from the end.The shaft is bent.The 4th loop was used and discarded.

• Brand Name: ELECTRODE,CUTTING,STERILE.24FR
• Common Device Name: MONOPOLAR SINGLE USE CUTTING LOOP
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, 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 90245 ; 4242188247
• MDR Report Key: 15477677
• Report Number: 9610617-2022-00272
• Device Sequence Number: 17541787
• Product Code: HIH
• UDI-Device Identifier: 04048551394540
• UDI-Public: 4048551394540
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/23/2022

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: 27050G-S
• Device Catalogue Number: 27050G-S
• Device Lot Number: 37FB6368
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/24/2022
• Initial Report FDA Received Date: 09/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown