MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP SILVERGLIDE BIPOLAR PRECISION FORCEPS BAYONET, 22CM / 1.2MM TIP; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	6720220012
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during testing in the sterile processing department of the user facility, insulation was peeling off near the tips of the device, posing the risk of a small component 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.Correction: b5: during service evaluation at the manufacturer facility, the technician found the device insulation was actually intact, and it was device tip plating material that was flaking off and missing.
Event or Problem Description
It was reported that during testing in the sterile processing department of the user facility, insulation was peeling off near the tips of the device, posing the risk of a small component being lost in a surgical site.There were no adverse consequences related to this event.During service evaluation at the manufacturer facility, the technician found the device insulation was actually intact, and it was the device tip plating material that was flaking off and missing.

• Brand Name: SILVERGLIDE BIPOLAR PRECISION FORCEPS BAYONET, 22CM / 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: zach baker ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 13929525
• Report Number: 3015967359-2022-00585
• Device Sequence Number: 6327700
• Product Code: GEI
• UDI-Device Identifier: 04546540532299
• UDI-Public: 04546540532299
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 05/17/2022

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: 6720220012
• Device Catalogue Number: 6720220012
• Device Lot Number: 366729
• 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: 03/22/2022
• Supplement Date Received by Manufacturer: 05/17/2022
• Initial Report FDA Received Date: 03/28/2022
• Supplement Report FDA Received Date: 05/18/2022
• 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