MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP SILVERGLIDE BIPOLAR FORCEPS SK BAYONET, 25CM / 1.2MM TIP; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	6750250012
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that in the sterile processing department at the user facility, a piece of insulation was found to be missing from 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 device evaluation results.
Event or Problem Description
It was reported that in the sterile processing department at the user facility, a piece of insulation was found to be missing from the device, posing the risk of a material being lost in a surgical site.There were no adverse consequences related to this event.

• Brand Name: SILVERGLIDE BIPOLAR FORCEPS SK BAYONET, 25CM / 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
• MDR Report Key: 11497046
• Report Number: 3015967359-2021-00182
• Device Sequence Number: 2775924
• Product Code: GEI
• UDI-Device Identifier: 04546540532589
• UDI-Public: 04546540532589
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 05/17/2021

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: 6750250012
• Device Catalogue Number: 6750250012
• Device Lot Number: 95441
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/09/2021
• Initial Date Received by Manufacturer: 02/19/2021
• Supplement Date Received by Manufacturer: 05/17/2021
• Initial Report FDA Received Date: 03/16/2021
• Supplement Report FDA Received Date: 05/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1