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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 05/18/2020
Event Type  malfunction  
Event Description
It was reported that during testing by the manufacturer sales representative at the user facility, the device tips were found to be chipped, posing the risk of a small component 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.
 
Event Description
It was reported that during testing by the manufacturer sales representative at the user facility, the device tips were found to be chipped, posing the risk of a small component being lost in a surgical site.There were no adverse consequences related to this event.
 
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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 Key10149364
MDR Text Key194996706
Report Number0001811755-2020-01448
Device Sequence Number1
Product Code GEI
UDI-Device Identifier04546540532541
UDI-Public04546540532541
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 12/28/2020
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
Device Operator Other
Device Model Number6750230015
Device Catalogue Number6750230015
Device Lot Number63739
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/19/2020
Initial Date Manufacturer Received 05/18/2020
Initial Date FDA Received06/12/2020
Supplement Dates Manufacturer Received12/28/2020
Supplement Dates FDA Received12/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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