MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SILVERGLIDE BIPOLAR STANDARD FORCEPS CUSHING, 19CM / 1.2MM TIP; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	6710190012
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Failure analysis is in progress; additional information will be submitted once the quality investigation is completed.
Event or Problem Description
The device was found to be fractured off the device, posing the risk of a small component being lost in a surgical site, during a service evaluation at the manufacturer facility.There were no adverse consequences related to this event.
Additional Manufacturer Narrative
Additional information: manufacture date follow-up report submitted to document device evaluation results.
Event or Problem Description
The device was found to be fractured off the device, posing the risk of a small component being lost in a surgical site, during a service evaluation at the manufacturer facility.There were no adverse consequences related to this event.

• Brand Name: SILVERGLIDE BIPOLAR STANDARD FORCEPS CUSHING, 19CM / 1.2MM TIP
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8446187
• Report Number: 0001811755-2019-00927
• Device Sequence Number: 14206752
• Product Code: GEI
• UDI-Device Identifier: 04546540532084
• UDI-Public: 04546540532084
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 05/03/2019

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: Health Professional
• Device Catalogue Number: 6710190012
• Device Lot Number: 304413
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2018
• Initial Date Received by Manufacturer: 02/25/2019
• Supplement Date Received by Manufacturer: 05/03/2019
• Initial Report FDA Received Date: 03/22/2019
• Supplement Report FDA Received Date: 05/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1