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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SILVERGLIDE BIPOLAR FORCEPS SK BAYONET, 23CM / 1.5MM TIP; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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STRYKER INSTRUMENTS-KALAMAZOO SILVERGLIDE BIPOLAR FORCEPS SK BAYONET, 23CM / 1.5MM TIP; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES Back to Search Results
Model Number 6750230015
Device Problem Flaked (1246)
Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/24/2020
Event Type  malfunction  
Event Description
During testing at the user facility, it was reported that pieces of insulation were found to be missing from the device, posing the risk of a material being lost in a surgical site.There was no patient involvement, no delay, no medical intervention, and no adverse consequences reported with this event.
 
Event Description
During testing at the user facility, it was reported that pieces of insulation were found to be missing from the device, posing the risk of a material being lost in a surgical site.There was no patient involvement, no delay, no medical intervention, and no adverse consequences reported with this event.
 
Manufacturer Narrative
Follow-up report submitted to document device evaluation results.
 
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Brand Name
SILVERGLIDE BIPOLAR FORCEPS SK BAYONET, 23CM / 1.5MM TIP
Type of Device
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key10409739
MDR Text Key203026491
Report Number0001811755-2020-02163
Device Sequence Number1
Product Code GEI
UDI-Device Identifier04546540532541
UDI-Public04546540532541
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 01/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number6750230015
Device Catalogue Number6750230015
Device Lot Number20190291
Was Device Available for Evaluation? Yes
Date Manufacturer Received01/26/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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