Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SILVERGLIDE PROSERIES BIPOLAR FORCEPS, BAYONET, 24CM / 2.0MM TIP; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

STRYKER INSTRUMENTS-KALAMAZOO SILVERGLIDE PROSERIES BIPOLAR FORCEPS, BAYONET, 24CM / 2.0MM TIP; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES Back to Search Results
Model Number 6730240020
Device Problem Flaked (1246)
Patient Problem No Patient Involvement (2645)
Event Date 05/22/2020
Event Type  malfunction  
Event Description
It was reported that during testing at the user facility, the device insulation was chipped, posing the risk of a small component being lost in a surgical site.There were no adverse consequences associated with this event.
 
Manufacturer Narrative
Correction: d4 lot number- unknown.Follow-up report submitted to document device evaluation results.H3 other text : device discarded at account.
 
Event Description
It was reported that during testing at the user facility, the device insulation was chipped, posing the risk of a small component being lost in a surgical site.There were no adverse consequences associated with this event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SILVERGLIDE PROSERIES BIPOLAR FORCEPS, BAYONET, 24CM / 2.0MM TIP
Type of Device
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key10169593
MDR Text Key195626063
Report Number0001811755-2020-01498
Device Sequence Number1
Product Code GEI
UDI-Device Identifier04546540696083
UDI-Public04546540696083
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 08/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number6730240020
Device Catalogue Number6730240020
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received08/14/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-