MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP SILVERGLIDE BIPOLAR STANDARD FORCEPS CUSHING, 19CM / 1.2MM TIP; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	6710190012
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during testing at the user facility, the device insulation was found to be coming off the device, posing the risk of a material being lost in a surgical site.There were no adverse consequences related to this event.
Event or Problem Description
It was reported that during testing at the user facility, the device insulation was found to be coming off the device, posing the risk of a material being lost in a surgical site.There were no adverse consequences related to this event.
Additional Manufacturer Narrative
Follow-up report submitted to document quality investigation results.H3 other text : device not available for evaluation.

• Brand Name: SILVERGLIDE BIPOLAR STANDARD FORCEPS CUSHING, 19CM / 1.2MM 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: colette chung ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 18221033
• Report Number: 3015967359-2023-02516
• Device Sequence Number: 20251793
• Product Code: GEI
• UDI-Device Identifier: 04546540532084
• UDI-Public: 04546540532084
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K992931
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 6710190012
• Device Lot Number: 409398
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/02/2023
• Supplement Date Received by Manufacturer: 04/03/2024
• Initial Report FDA Received Date: 11/28/2023
• Supplement Report FDA Received Date: 04/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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