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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SILVERGLIDE BIPOLAR PRECISION FORCEPS BAYONET, 24CM / 1.2MM TIP; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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STRYKER INSTRUMENTS-KALAMAZOO SILVERGLIDE BIPOLAR PRECISION FORCEPS BAYONET, 24CM / 1.2MM TIP; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES Back to Search Results
Model Number 6720240012
Medical Device Problem Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 11/24/2020
Type of Reportable Event Malfunction
Event or Problem Description
The device guide stop was found to be fractured 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, 24CM / 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 Key11032153
Report Number0001811755-2020-03495
Device Sequence Number13769332
Product Code GEI
UDI-Device Identifier04546540532336
UDI-Public04546540532336
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) 12/17/2020
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 Other
Device Model Number6720240012
Device Catalogue Number6720240012
Device Lot Number344178
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/28/2020
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 11/24/2020
Initial Report FDA Received Date12/17/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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