MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SILVERGLIDE BIPOLAR PRECISION FORCEPS BAYONET, 19CM / 1.5MM TIP; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	6720190015
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/14/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer sales representative stated the device insulation is chipping, posing the risk of a small component being lost in a surgical site.Attempts are being made to obtain additional information.
Event or Problem Description
The manufacturer sales representative stated the device insulation is chipping, posing the risk of a small component being lost in a surgical site.Attempts are being made to obtain additional information.
Additional Manufacturer Narrative
Follow-up report submitted to document device evaluation results.

• Brand Name: SILVERGLIDE BIPOLAR PRECISION FORCEPS BAYONET, 19CM / 1.5MM TIP
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8056649
• Report Number: 0001811755-2018-02430
• Device Sequence Number: 1683546
• Product Code: GEI
• UDI-Device Identifier: 04546540532244
• UDI-Public: 04546540532244
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K992931
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2019

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: No Information
• Device Catalogue Number: 6720190015
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/14/2018
• Supplement Date Received by Manufacturer: 01/24/2019
• Initial Report FDA Received Date: 11/09/2018
• Supplement Report FDA Received Date: 01/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1