MAUDE Adverse Event Report: KARL STORZ SE & CO. KG FORCEPS,OPTICAL,GRASPING; OPTICAL GRASPING FORCEPS

Model Number	27072F
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device has not yet returned to the factory.
Event or Problem Description
As per a manufacturer incident report we received from the factory in (b)(6): as reported: during a removal of a bladder stone, a screw broke off and 3 metal particles fell in the bladder due to which they were laboriously removed.The surgery time was extended by 30 minutes.
Additional Manufacturer Narrative
The internal investigation shows no indication for a material or manufacturing related issue.The device was returned on 14.09.2021 to the manufacture for investigation.Upon the evaluation, it could be confirmed that the grasping forceps broke distally into several parts in the area of the joint.Also, strong deformations can be seen at the riveted points, which indicates that a high level of force has been applied, i.E.User error.A warning to not overload the device by exerting too much force and to never bend back the device into shape by user was already included in the related ifu.Although it was reported, that 3 metal particles fell into the pateint´s bladder, which caused an operation extension of 30 mins, due to the fact, that the incident was determined to be caused by an operator error and no injury to patient, user or third occurred.Furthermore, the severity of the potential harm is assesed as reversible in the related risk file and the risk of occurrence is rated as negligible, as the event did not and might not lead to death or serious deterioration in the state of health.In addition, according to the complaint analysis no serious injuries were reported in relation to the described issue.

• Brand Name: FORCEPS,OPTICAL,GRASPING
• Common Device Name: OPTICAL GRASPING FORCEPS
• 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 ave; el segundo, CA 90245-5017 ; 4242188738
• MDR Report Key: 11408002
• Report Number: 9610617-2021-00022
• Device Sequence Number: 19966507
• Product Code: OCZ
• UDI-Device Identifier: 04048551079263
• UDI-Public: 4048551079263
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K950434
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 27072F
• Device Catalogue Number: 27072F
• Device Lot Number: TR01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2021
• Supplement Date Received by Manufacturer: 10/28/2021
• Initial Report FDA Received Date: 03/03/2021
• Supplement Report FDA Received Date: 03/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown