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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SILVERGLIDE PROSERIES BIPOLAR FORCEPS, BAYONET, 24CM / 1.5MM TIP; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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STRYKER INSTRUMENTS-KALAMAZOO SILVERGLIDE PROSERIES BIPOLAR FORCEPS, BAYONET, 24CM / 1.5MM TIP; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES Back to Search Results
Catalog Number 6730240015
Medical Device Problem Code Flaked (1246)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 05/09/2019
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that during testing at the manufacturer facility insulation was chipped off and missingfrom the device, posing the risk of a small component being lost in a surgical site.There were no adverse consequences related to this event.
 
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Brand Name
SILVERGLIDE PROSERIES BIPOLAR FORCEPS, BAYONET, 24CM / 1.5MM TIP
Common Device Name
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key8668137
Report Number0001811755-2019-01896
Device Sequence Number2260732
Product Code GEI
UDI-Device Identifier04546540696076
UDI-Public04546540696076
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
PMA/510(K) Number
K992931
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 06/04/2019
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 Other
Device Catalogue Number6730240015
Device Lot Number63747
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/07/2019
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/09/2019
Initial Report FDA Received Date06/04/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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