MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP SILVERGLIDE PROSERIES BIPOLAR FORCEPS, BAYONET, 22CM / 2.0MM TIP; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	6730220020
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported pieces of insulation were found to be missing from the device, posing the risk of a material being lost in a surgical site.Attempts are being made to obtain additional information.
Additional Manufacturer Narrative
Additional information: d9 device evaluation: follow-up report submitted to document device evaluation results.
Event or Problem Description
It was reported pieces of insulation were found to be missing from the device, posing the risk of a material being lost in a surgical site.Attempts are being made to obtain additional information.

• Brand Name: SILVERGLIDE PROSERIES BIPOLAR FORCEPS, BAYONET, 22CM / 2.0MM TIP
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: kelsey barla ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 20008173
• Report Number: 3015967359-2024-01699
• Device Sequence Number: 17956485
• Product Code: GEI
• UDI-Device Identifier: 04546540695970
• UDI-Public: (01)04546540695970(10)224529
• 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): 11/22/2024

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
• Device Catalogue Number: 6730220020
• Device Lot Number: 224529
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/23/2024
• Supplement Date Received by Manufacturer: 11/11/2024
• Initial Report FDA Received Date: 08/20/2024
• Supplement Report FDA Received Date: 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown