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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP SILVERGLIDE BIPOLAR PRECISION FORCEPS BAYONET, 24CM / 1.5MM TIP; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP SILVERGLIDE BIPOLAR PRECISION FORCEPS BAYONET, 24CM / 1.5MM TIP; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES Back to Search Results
Model Number 6720240015
Device Problem Flaked (1246)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/20/2020
Event Type  malfunction  
Event Description
It was reported that during inspection at the user facility, pieces of insulation were found 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.
 
Manufacturer Narrative
Follow-up report submitted to document device evaluation results.H3 other text : product not available.
 
Event Description
It was reported that during inspection at the user facility, pieces of insulation were found 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.
 
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Brand Name
SILVERGLIDE BIPOLAR PRECISION FORCEPS BAYONET, 24CM / 1.5MM TIP
Type of Device
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Manufacturer (Section D)
STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
1941 stryker way
portage MI 49002
MDR Report Key10862660
MDR Text Key217091600
Report Number0001811755-2020-03207
Device Sequence Number1
Product Code GEI
UDI-Device Identifier04546540532343
UDI-Public04546540532343
Combination Product (y/n)N
PMA/PMN Number
K992931
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 04/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number6720240015
Device Catalogue Number6720240015
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received04/23/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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