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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO ROCKER-SWITCH SMOKE EVAC PENCIL, COATED; ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES
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STRYKER INSTRUMENTS-KALAMAZOO ROCKER-SWITCH SMOKE EVAC PENCIL, COATED; ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES Back to Search Results
Catalog Number 0703047000
Device Problem No Audible Alarm (1019)
Patient Problem Abrasion (1689)
Event Date 04/14/2021
Event Type  Injury  
Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Device not returned.
 
Event Description
It was reported that during a carotid endarterectomy procedure, the doctor placed the cautery pencil down and placed a drape towel on top the pencil across the patient's chest and not in safety holder.It was also reported that a small open cautery pencil wound over the left breast area was noted.It was further reported that the cautery unit nor the smoke evacuation unit sounded "in use" as it normally does.Both the cautery pencil, cautery grounding pad, and the unit were replaced.It was further reported that the wound was closed and dressed appropriately in surgery which resulted in a fifteen minute delay, the procedure was completed successfully.
 
Manufacturer Narrative
H6: the quality investigation is complete.H3 other text : device not returned.
 
Event Description
It was reported that during a carotid endarterectomy procedure, the doctor placed the cautery pencil down and placed a drape towel on top the pencil across the patient's chest and not in safety holder.It was also reported that a small open cautery pencil wound over the left breast area was noted.It was further reported that the cautery unit nor the smoke evacuation unit sounded "in use" as it normally does.Both the cautery pencil, cautery grounding pad, and the unit were replaced.It was further reported that the wound was closed and dressed appropriately in surgery which resulted in a fifteen minute delay, the procedure was completed successfully.
 
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Brand Name
ROCKER-SWITCH SMOKE EVAC PENCIL, COATED
Type of Device
ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key11812032
MDR Text Key250192725
Report Number0001811755-2021-00765
Device Sequence Number1
Product Code GEI
UDI-Device Identifier37613327117203
UDI-Public37613327117203
Combination Product (y/n)N
PMA/PMN Number
K143145
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 06/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/01/2023
Device Catalogue Number0703047000
Device Lot Number2040009
Was Device Available for Evaluation? No
Date Manufacturer Received06/14/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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