MAUDE Adverse Event Report: KARL STORZ SE & CO. KG BIPOLAR ELECTRODE 24/26 FR; CUTTING LOOP

Model Number	27040GP1-S
Medical Device Problem Codes	Material Separation (1562); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product has been discarded by the facility.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.The event is filed under internal karl storz complaint id (b)(4).
Event or Problem Description
According to the information we received, the electrode item 27040gp1-s bipolar cutting loop was missing from the electrode.The loop was found inside the patient's bladder, it was retrieved and the turp procedure completed with no harm to the patient.
Additional Manufacturer Narrative
Kst/mfr.Has provided the complaint product investigation plan and report which is based on the non return of product.Report conclusion root cause is according to the customer, the cutting loop was pulled out in the distal area.The reason for this could be, for example, excessive tensile force on the loop without having activated the hf current.However, since the article was not sent in for examination, no more precise statement can be made on this.The ifu points out the correct handling.The event is filed under internal karl storz complaint id (b)(4).

• Brand Name: BIPOLAR ELECTRODE 24/26 FR
• Common Device Name: CUTTING LOOP
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, deu, ; GM
• Manufacturer (Section G): KARL STORZ SE & CO.KG; dr.-karl-storz -strasse 34; 78532; tuttlingen, deu, ; GM
• Manufacturer Contact: anja fair ; 2151 east grand avenue; el segundo, CA 90245-5017 ; 4242188738
• MDR Report Key: 16768903
• Report Number: 9610617-2023-00083
• Device Sequence Number: 12371300
• Product Code: FAS
• UDI-Device Identifier: 04048551393482
• UDI-Public: 4048551393482
• Combination Product (Y/N): N
• Initial Reporter State: VT
• 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,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2023

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: 27040GP1-S
• Device Catalogue Number: 27040GP1-S
• Device Lot Number: 37KB3555
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2023
• Supplement Date Received by Manufacturer: 03/20/2023
• Initial Report FDA Received Date: 04/19/2023
• Supplement Report FDA Received Date: 08/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Male