MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SILVERGLIDE BIPOLAR PRECISION FORCEPS BAYONET, 24CM / 0.4MM TIP; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	6720240004
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/28/2020
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.
Additional Manufacturer Narrative
Additional information: h4-manufacture date.Follow-up report submitted to document device evaluation results.
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 PRECISION FORCEPS BAYONET, 24CM / 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: 9719497
• Report Number: 0001811755-2020-00471
• Device Sequence Number: 355228
• Product Code: GEI
• UDI-Device Identifier: 04546540532312
• UDI-Public: 04546540532312
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K992931
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2020

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 Model Number: 6720240004
• Device Catalogue Number: 6720240004
• Device Lot Number: 335726
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/03/2020
• Supplement Date Received by Manufacturer: 08/18/2020
• Initial Report FDA Received Date: 02/18/2020
• Supplement Report FDA Received Date: 08/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1