MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SILVERGLIDE BIPOLAR FORCEPS, SF CUSHING, 20CM / 0.7MM TIP; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	6710210007
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported pieces of insulation were found to be missing from the device, posing the risk of a material being lost in a surgical site.There was no patient involvement, no delay, no medical intervention, and no adverse consequences reported with this event.
Event or Problem Description
The user facility reported pieces of insulation were found to be missing from the device, posing the risk of a material being lost in a surgical site.There was no patient involvement, no delay, no medical intervention, and no adverse consequences reported with this event.
Additional Manufacturer Narrative
Additional information: h4-manufacture date.Follow-up report submitted to document device evaluation results.

• Brand Name: SILVERGLIDE BIPOLAR FORCEPS, SF CUSHING, 20CM / 0.7MM TIP
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 10409809
• Report Number: 0001811755-2020-02162
• Device Sequence Number: 2642365
• Product Code: GEI
• UDI-Device Identifier: 04546540714879
• UDI-Public: 04546540714879
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: K992931
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2020

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: 6710210007
• Device Catalogue Number: 6710210007
• Device Lot Number: 324222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2020
• Initial Date Received by Manufacturer: 07/21/2020
• Supplement Date Received by Manufacturer: 10/28/2020
• Initial Report FDA Received Date: 08/14/2020
• Supplement Report FDA Received Date: 11/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1