MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CUTTING LOOP, BIPOLAR; BIPOLAR SINGLE USE CUTTING LOOP

Model Number 27040GP130-S

Device Problem Material Separation (1562)

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

Event Date 06/13/2022

Event Type  malfunction  

Event Description

During a procedure, the loop completely came off the tip of the electrode.There was no reported harm to the patient and the procedure was completed.

Manufacturer Narrative

Product has not been returned by facility, therefore product has not been evaluated.

Manufacturer Narrative

Corrected lot code and added manufactured date.Added the evaluation findings below: the distal cutting loop is dislodged from housing shaft.The distal plastic on the loop and the insulation has melted.Black residue is seen.

• Brand Name: CUTTING LOOP, BIPOLAR
• Type of Device: BIPOLAR 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
• Manufacturer Contact: anja fair ; 2151 e. grand avenue; el segundo, CA 90245 ; 4242188247
• MDR Report Key: 15053012
• MDR Text Key: 296852535
• Report Number: 9610617-2022-00125
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 04048551393864
• UDI-Public: 4048551393864
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061541
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/19/2022

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
• Device Operator: Health Professional
• Device Model Number: 27040GP130-S
• Device Catalogue Number: 27040GP130-S
• Device Lot Number: OP02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/13/2022
• Initial Date FDA Received: 07/19/2022
• Supplement Dates Manufacturer Received: 06/13/2022
• Supplement Dates FDA Received: 08/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2020
• 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