MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP SILVERGLIDE BIPOLAR FORCEPS SK BAYONET, 28CM / 1.2MM TIP; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number 6750280012

Device Problem Flaked (1246)

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

Event Date 11/15/2023

Event Type  malfunction  

Event Description

It was reported that during testing of the device at the user facility, the device tips were found to be chipped and silver plating material was missing, posing the risk of a small component being lost in a surgical site.There were no adverse consequences related to this event.

Manufacturer Narrative

Additional information: d9 the quality investigation is complete.H3 other text : device not available for evaluation.

Event Description

It was reported that during testing of the device at the user facility, the device tips were found to be chipped and silver plating material was missing, posing the risk of a small component being lost in a surgical site.There were no adverse consequences related to this event.

• Brand Name: SILVERGLIDE BIPOLAR FORCEPS SK BAYONET, 28CM / 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: colette chung ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 18323312
• MDR Text Key: 330468036
• Report Number: 3015967359-2023-02591
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04546540532626
• UDI-Public: 04546540532626
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6750280012
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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