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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SILVERGLIDE BIPOLAR PRECISION FORCEPS BAYONET, 22CM / 0.4MM TIP; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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STRYKER INSTRUMENTS-KALAMAZOO SILVERGLIDE BIPOLAR PRECISION FORCEPS BAYONET, 22CM / 0.4MM TIP; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES Back to Search Results
Catalog Number 6720220004
Medical Device Problem Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 04/11/2019
Type of Reportable Event Malfunction
Event or Problem Description
The device guide stop was found to be disassembled from 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.
 
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Brand Name
SILVERGLIDE BIPOLAR PRECISION FORCEPS BAYONET, 22CM / 0.4MM TIP
Common Device Name
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key8588328
Report Number0001811755-2019-01601
Device Sequence Number2191667
Product Code GEI
UDI-Device Identifier04546540532275
UDI-Public04546540532275
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) 05/07/2019
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 Number6720220004
Device Lot Number265808
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/08/2019
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/11/2019
Initial Report FDA Received Date05/07/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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