MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP SILVERGLIDE PROSERIES BIPOLAR FORCEPS, BAYONET, 19CM / 2.0MM TIP; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number 6730190020

Device Problem Flaked (1246)

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

Event Date 02/09/2022

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

Follow-up report submitted to document device evaluation results.H3 other text: product not available.

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 PROSERIES BIPOLAR FORCEPS, BAYONET, 19CM / 2.0MM 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: 13720527
• MDR Text Key: 286934928
• Report Number: 3015967359-2022-00478
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04546540695895
• UDI-Public: 04546540695895
• 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: 05/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6730190020
• Device Catalogue Number: 6730190020
• Device Lot Number: 70724
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/04/2022
• Was Device Evaluated by Manufacturer?: No
• 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