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

Model Number 27050G-S

Device Problems Energy Output Problem (1431); Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/23/2022

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 306357504
• Report Number: 9610617-2022-00272
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04048551394540
• UDI-Public: 4048551394540
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K882270
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27050G-S
• Device Catalogue Number: 27050G-S
• Device Lot Number: 37FB6368
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other