MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SILVERGLIDE PROSERIES BIPOLAR FORCEPS, BAYONET, 19CM / 0.4MM TIP; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	6730190004
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received for evaluation; additional information will be submitted once the quality investigation is completed.
Event or Problem Description
The user facility reported pieces of insulation were found to be missing from the device, posing the risk of a material being lost in a surgical site.There was no patient involvement, no delay, no medical intervention, and no adverse consequences reported with this event.
Additional Manufacturer Narrative
Follow-up report submitted to document device evaluation results.
Event or Problem Description
The user facility reported pieces of insulation were found to be missing from the device, posing the risk of a material being lost in a surgical site.There was no patient involvement, no delay, no medical intervention, and no adverse consequences reported with this event.

• Brand Name: SILVERGLIDE PROSERIES BIPOLAR FORCEPS, BAYONET, 19CM / 0.4MM TIP
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8203040
• Report Number: 0001811755-2018-02911
• Device Sequence Number: 1710505
• Product Code: GEI
• UDI-Device Identifier: 04546540695840
• UDI-Public: 04546540695840
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 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: 6730190004
• Device Lot Number: 50004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2018
• Initial Date Received by Manufacturer: 12/06/2018
• Supplement Date Received by Manufacturer: 04/17/2019
• Initial Report FDA Received Date: 12/28/2018
• 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