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 ROCKER-SWITCH SMOKE EVAC PENCIL, UNCOATED; ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND 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 ROCKER-SWITCH SMOKE EVAC PENCIL, UNCOATED; ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES Back to Search Results
Catalog Number 0703047001
Device Problem Arcing (2583)
Patient Problem Superficial (First Degree) Burn (2685)
Event Date 09/01/2023
Event Type  malfunction  
Event Description
It was reported that during a procedure an e-sep pencil was being used when it arced, and a surgeon was burned through their glove.The burn was 3mm in size on their forearm.No medical intervention or additional treatment was required and no permanent damage or infection is expected.The procedure was completed successfully without a delay.This is 1 of 3 events that occurred at the same account.
 
Manufacturer Narrative
H6: a follow up report will be filed once the quality investigation is complete.H3 other text : awaiting confirmation device is available for return.
 
Manufacturer Narrative
Correction d9/h3: device not available for return.H6: the quality investigation is complete.H3 other text: device not available for return.
 
Event Description
It was reported that during a procedure an e-sep pencil was being used when it arced, and a surgeon was burned through their glove.The burn was 3mm in size on their forearm.No medical intervention or additional treatment was required and no permanent damage or infection is expected.The procedure was completed successfully without a delay.This is 1 of 3 events that occurred at the same account.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ROCKER-SWITCH SMOKE EVAC PENCIL, UNCOATED
Type of Device
ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer (Section G)
STRYKER INSTRUMENTS-IRELAND
instruments division
carrigtwohill bus. & tech park
carrigtwohill NA
EI   NA
Manufacturer Contact
colette chung
instruments division
carrigtwohill bus. & tech park
carrigtwohill NA
EI   NA
214532900
MDR Report Key18221019
MDR Text Key329161596
Report Number0001811755-2023-00238
Device Sequence Number1
Product Code GEI
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K143145
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 02/08/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/28/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0703047001
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received01/25/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-