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

Device Problem Flaked (1246)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/21/2022

Event Type  malfunction  

Event 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.

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 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
• Type of Device: 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
• MDR Text Key: 288038516
• Report Number: 3015967359-2022-00585
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04546540532299
• UDI-Public: 04546540532299
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K992931
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 05/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1