MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SILVERGLIDE PROSERIES BIPOLAR FORCEPS, BAYONET, 24CM / 2.0MM TIP; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number 6730240020

Device Problem Flaked (1246)

Patient Problem No Patient Involvement (2645)

Event Date 06/03/2020

Event Type  malfunction  

Event Description

It was reported that during testing by the manufacturer sales representative at the user facility, pieces of insulation were 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.

Event Description

It was reported that during testing by the manufacturer sales representative at the user facility, pieces of insulation were 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.

Manufacturer Narrative

Correction: d4 lot number- unknown.Follow-up report submitted to document device evaluation results.H3 other text : device discarded at account.

• Brand Name: SILVERGLIDE PROSERIES BIPOLAR FORCEPS, BAYONET, 24CM / 2.0MM TIP
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 10196900
• MDR Text Key: 197176611
• Report Number: 0001811755-2020-01561
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04546540696083
• UDI-Public: 04546540696083
• Combination Product (y/n): N
• PMA/PMN Number: K992931
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 08/17/2020

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
• Device Operator: Other
• Device Model Number: 6730240020
• Device Catalogue Number: 6730240020
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/03/2020
• Initial Date FDA Received: 06/25/2020
• Supplement Dates Manufacturer Received: 08/13/2020
• Supplement Dates FDA Received: 08/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1