MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SILVERGLIDE BIPOLAR STANDARD FORCEPS CUSHING, 21CM / 2.0MM TIP; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	6710210020
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/12/2019
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional Manufacturer Narrative
Follow-up report submitted to document device evaluation results.
Event or Problem 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.

• Brand Name: SILVERGLIDE BIPOLAR STANDARD FORCEPS CUSHING, 21CM / 2.0MM TIP
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 9413260
• Report Number: 0001811755-2019-03944
• Device Sequence Number: 19866053
• Product Code: GEI
• UDI-Device Identifier: 04546540714909
• UDI-Public: 04546540714909
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 03/13/2020

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
• Operator of Device: Other
• Device Model Number: 6710210020
• Device Catalogue Number: 6710210020
• Device Lot Number: 222285
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2019
• Initial Date Received by Manufacturer: 11/12/2019
• Supplement Date Received by Manufacturer: 03/10/2020
• Initial Report FDA Received Date: 12/04/2019
• Supplement Report FDA Received Date: 03/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1