MAUDE Adverse Event Report: KARL STORZ SE & CO. KG FROCEPS SINGLE ACTION JAW; FLEXIBLE GRASPING FORCEPS

Model Number	11161KB
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product has been returned; evaluation is pending.
Event or Problem Description
During a left frontal burr hole for fenestration of a large cyst, the jaws of the grasper locked in open position while inside the flexible scope; which was in the patient, requiring the scope with graspers to be removed from the patient.The procedure was completed without use of another grasper.There was no harm to the patient.

• Brand Name: FROCEPS SINGLE ACTION JAW
• Common Device Name: FLEXIBLE GRASPING FORCEPS
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, gm
• MDR Report Key: 11776115
• Report Number: 9610617-2021-00044
• Device Sequence Number: 17003575
• Product Code: GWG
• UDI-Device Identifier: 04048551050477
• UDI-Public: 4048551050477
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K002788
• 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): 05/04/2021

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: 11161KB
• Device Catalogue Number: 11161KB
• Device Lot Number: NP01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2021
• Initial Report FDA Received Date: 05/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 20 MO
• Patient Weight: 7