MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SILVERGLIDE BIPOLAR FORCEPS SK BAYONET, 20CM / 0.4MM TIP; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	6750200004
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/25/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The device guidestop disassembled, posing the risk of a small component being lost in a surgical site, after a procedure 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.
Event or Problem Description
The device guidestop disassembled, posing the risk of a small component being lost in a surgical site, after a procedure at the user facility.There was no patient involvement, no delay, no medical intervention, and no adverse consequences.

• Brand Name: SILVERGLIDE BIPOLAR FORCEPS SK BAYONET, 20CM / 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: 8004967
• Report Number: 0001811755-2018-01788
• Device Sequence Number: 427554
• Product Code: GEI
• UDI-Device Identifier: 04546540532480
• UDI-Public: 04546540532480
• Combination Product (Y/N): N
• 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): 12/21/2018

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: 6750200004
• Device Lot Number: 1N04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2018
• Initial Date Received by Manufacturer: 09/27/2018
• Supplement Date Received by Manufacturer: 12/20/2018
• Initial Report FDA Received Date: 10/25/2018
• Supplement Report FDA Received Date: 12/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1