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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO BIPOLAR GENERATOR; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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STRYKER INSTRUMENTS-KALAMAZOO BIPOLAR GENERATOR; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES Back to Search Results
Model Number 6700-343-500
Medical Device Problem Codes Energy Output Problem (1431); Intermittent Energy Output (4025)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 11/04/2020
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that during testing at the user facility, the device had intermittent energy output, a condition which may pose the risk of insufficient coagulation and increased bleeding.There were no adverse consequences related to this event.
 
Event or Problem Description
It was reported that during testing at the user facility, the device had intermittent energy output, a condition which may pose the risk of insufficient coagulation and increased bleeding.There were no adverse consequences related to this event.
 
Additional Manufacturer Narrative
Follow-up report submitted to document device evaluation results.
 
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Brand Name
BIPOLAR GENERATOR
Common Device Name
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key10862795
Report Number0001811755-2020-03216
Device Sequence Number16803217
Product Code GEI
UDI-Device Identifier07613327303889
UDI-Public07613327303889
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
K050364
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 02/04/2021
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
Operator of Device Other
Device Model Number6700-343-500
Device Catalogue Number6700313500
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/10/2020
Initial Date Received by Manufacturer 11/04/2020
Supplement Date Received by Manufacturer02/03/2021
Initial Report FDA Received Date11/18/2020
Supplement Report FDA Received Date02/04/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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