MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SILVERGLIDE BIPOLAR STANDARD FORCEPS ADSON12.5CM / 1.2MM TIP; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	6715125012
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/28/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The device was reported to be chipped, posing the risk of a small component being lost in a surgical site, found during testing at the user facility.There was no patient involvement, no delay, no medical intervention, and no adverse consequences.
Additional Manufacturer Narrative
Follow-up report submitted to document device evaluation results.: product not returned for evaluation.
Event or Problem Description
The device was reported to be chipped, posing the risk of a small component being lost in a surgical site, found during testing at the user facility.There was no patient involvement, no delay, no medical intervention, and no adverse consequences.

• Brand Name: SILVERGLIDE BIPOLAR STANDARD FORCEPS ADSON12.5CM / 1.2MM TIP
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8130529
• Report Number: 0001811755-2018-02638
• Device Sequence Number: 1487088
• Product Code: GEI
• UDI-Device Identifier: 04546540532152
• UDI-Public: 04546540532152
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K992931
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2019

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 Catalogue Number: 6715125012
• Device Lot Number: 255786
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/08/2018
• Supplement Date Received by Manufacturer: 04/16/2019
• Initial Report FDA Received Date: 12/04/2018
• Supplement Report FDA Received Date: 04/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1