MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SILVERGLIDE PROSERIES BIPOLAR FORCEPS, BAYONET, 24CM / 2.0MM TIP; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	6730240020
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/22/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during testing at the user facility, the device insulation was chipped, posing the risk of a small component being lost in a surgical site.There were no adverse consequences associated with this event.
Additional Manufacturer Narrative
Correction: d4 lot number- unknown.Follow-up report submitted to document device evaluation results.H3 other text : device discarded at account.
Event or Problem Description
It was reported that during testing at the user facility, the device insulation was chipped, posing the risk of a small component being lost in a surgical site.There were no adverse consequences associated with this event.

• Brand Name: SILVERGLIDE PROSERIES BIPOLAR FORCEPS, BAYONET, 24CM / 2.0MM TIP
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 10169593
• Report Number: 0001811755-2020-01498
• Device Sequence Number: 1659566
• Product Code: GEI
• UDI-Device Identifier: 04546540696083
• UDI-Public: 04546540696083
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 08/17/2020

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: Other
• Device Model Number: 6730240020
• Device Catalogue Number: 6730240020
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/22/2020
• Supplement Date Received by Manufacturer: 08/14/2020
• Initial Report FDA Received Date: 06/18/2020
• Supplement Report FDA Received Date: 08/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1