MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP SILVERGLIDE BIPOLAR PRECISION FORCEPS BAYONET, 22CM / 1.5MM TIP; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	6720220015
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during testing at the user facility, the insulation was observed 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
Correction: d9; h3.The device was not returned for evaluation; therefore, a root cause could not be determined for the event.
Event or Problem Description
It was reported that during testing at the user facility, the insulation was observed 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
In accordance to with the "final guidance on medical device reporting for manufacturers" issued on november 7, 2016, stryker instruments will no longer report the hazard of the tip of device flaking or material flaking off of the device for our silverglide and bipolar forceps product lines (product code gei), as this hazard has not caused or contributed to any serious injuries in at least two years.No new mdrs will be generated for this malfunction moving forward.Additionally, supplemental records may be filed for any past reported events that are still pending evaluation or obtain new information.Should a new serious adverse event occur attributed to this hazard, mdr reporting will resume.
Event or Problem Description
No new information.

• Brand Name: SILVERGLIDE BIPOLAR PRECISION FORCEPS BAYONET, 22CM / 1.5MM TIP
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: kelsey barla ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 22194381
• Report Number: 3015967359-2025-01107
• Device Sequence Number: 12909886
• Product Code: GEI
• UDI-Device Identifier: 04546540532305
• UDI-Public: (01)04546540532305(10)404333
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,Followup
• Report Date (Section B): 08/06/2025

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 Catalogue Number: 6720220015
• Device Lot Number: 404333
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/19/2025
• Supplement Date Received by Manufacturer: 07/01/2025; 08/06/2025
• Initial Report FDA Received Date: 06/12/2025
• Supplement Report FDA Received Date: 07/02/2025; 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown