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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SILVERGLIDE BIPOLAR FORCEPS, SF CUSHING, 20CM / 0.7MM TIP; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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STRYKER INSTRUMENTS-KALAMAZOO SILVERGLIDE BIPOLAR FORCEPS, SF CUSHING, 20CM / 0.7MM TIP; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES Back to Search Results
Model Number 6710210007
Device Problem Flaked (1246)
Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/21/2020
Event Type  malfunction  
Event Description
The user facility reported 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
The user facility reported 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
Additional information: h4-manufacture date.Follow-up report submitted to document device evaluation results.
 
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Brand Name
SILVERGLIDE BIPOLAR FORCEPS, SF CUSHING, 20CM / 0.7MM TIP
Type of Device
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key10409809
MDR Text Key203020952
Report Number0001811755-2020-02162
Device Sequence Number1
Product Code GEI
UDI-Device Identifier04546540714879
UDI-Public04546540714879
Combination Product (y/n)N
PMA/PMN Number
K992931
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 11/02/2020
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 Health Professional
Device Model Number6710210007
Device Catalogue Number6710210007
Device Lot Number324222
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/04/2020
Date Manufacturer Received10/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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