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	10/07/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The device guide stop was found to be disassembled from the device, posing the risk of a small component being lost in a surgical site, prior to 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: 9271830
• Report Number: 0001811755-2019-03625
• Device Sequence Number: 10803261
• 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
• Report Date (Section B): 11/04/2019

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: 6750200004
• Device Lot Number: 1N04
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/10/2019
• Initial Report FDA Received Date: 11/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1