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

Model Number	28162ZE
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The item has not been returned by the facility, therefore, no evaluation can be done.Per the picture of the instrument provided by the doctor, it appears to be broken and a small piece of metal is not present.
Event or Problem Description
Per the doctor while performing a biopsy for a intraventricular brain tumor, on the third biopsy, the forceps would not grasp and the instrument was removed.Mri was done and it appears to be a very small granular piece remained there.The procedure was completed with no further intervention to the patient.

• Brand Name: BIOPSY CUP FORCEPS
• Common Device Name: SINGLE ACTION JAW, BIOPSY CUP FORCEPS
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, gm,
• MDR Report Key: 10431068
• Report Number: 9610617-2020-00089
• Device Sequence Number: 3273693
• Product Code: GWG
• UDI-Device Identifier: 04048551098585
• UDI-Public: 4048551098585
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K982837
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/19/2020

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: 28162ZE
• Device Catalogue Number: 28162ZE
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/20/2020
• 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: Required Intervention
• Patient Age: 19 YR