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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SILVERGLIDE BIPOLAR FORCEPS, SP BAYONET, 22CM / 0.7MM TIP; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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STRYKER INSTRUMENTS-KALAMAZOO SILVERGLIDE BIPOLAR FORCEPS, SP BAYONET, 22CM / 0.7MM TIP; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES Back to Search Results
Model Number 6720220007
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 01/07/2021
Type of Reportable Event Malfunction
Event or Problem Description
The device tip was found to be fractured off and missing 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 FORCEPS, SP BAYONET, 22CM / 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 Key11186250
Report Number0001811755-2021-00116
Device Sequence Number17033363
Product Code GEI
UDI-Device Identifier04546540532282
UDI-Public04546540532282
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) 01/18/2021
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 Number6720220007
Device Catalogue Number6720220007
Device Lot Number349191
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/23/2020
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 01/07/2021
Initial Report FDA Received Date01/18/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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