MAUDE Adverse Event Report: KARL STORZ SE & CO. KG BIOPSY FORCEPS; DOUBLE ACTION JAW BIOPSY FORCEPS

Model Number	28160ZJ
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The linkage of the jaw broke off as shown in the image.The product has been in use over 6 years and may have stress overload at jaws.
Event or Problem Description
Per the customer, allegedly during a endoscopic ventriculoscopy procedure the butterfly hinge of the grasper broke inside the patient.The procedure was completed and per the doctor the follow up imaging did not show any retained object.

• Brand Name: BIOPSY FORCEPS
• Common Device Name: DOUBLE ACTION JAW BIOPSY FORCEPS
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, gm
• MDR Report Key: 10690078
• Report Number: 9610617-2020-00109
• Device Sequence Number: 3457265
• Product Code: GWG
• UDI-Device Identifier: 04048551097199
• UDI-Public: 4048551097199
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K982837
• 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): 10/14/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 28160ZJ
• Device Catalogue Number: 28160ZJ
• Device Lot Number: NV
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/17/2020
• Initial Report FDA Received Date: 10/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1