MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SILVERGLIDE BIPOLAR STANDARD FORCEPS ADSON12.5CM / 1.2MM TIP; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	6715125012
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/13/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported material was found to be missing from the tips of the device during testing prior to a procedure, posing the risk of a material being lost in a surgical site.The procedure was completed successfully, and there was no surgical delay, no medical intervention, and no adverse consequences reported with this event.
Additional Manufacturer Narrative
Follow-up report submitted to document device evaluation results.
Event or Problem Description
The user facility reported material was found to be missing from the tips of the device during testing prior to a procedure, posing the risk of a material being lost in a surgical site.The procedure was completed successfully, and there was no surgical delay, no medical intervention, and no adverse consequences reported with this event.

• Brand Name: SILVERGLIDE BIPOLAR STANDARD FORCEPS ADSON12.5CM / 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: 9950005
• Report Number: 0001811755-2020-00896
• Device Sequence Number: 2319992
• Product Code: GEI
• UDI-Device Identifier: 04546540532152
• UDI-Public: 04546540532152
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K992931
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2020

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: Health Professional
• Device Model Number: 6715125012
• Device Catalogue Number: 6715125012
• Device Lot Number: 328595
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/13/2020
• Supplement Date Received by Manufacturer: 08/18/2020
• Initial Report FDA Received Date: 04/10/2020
• Supplement Report FDA Received Date: 08/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1