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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. CAUTERY PENCIL FROM MAJOR ORTHO PACK

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MEDLINE INDUSTRIES INC. CAUTERY PENCIL FROM MAJOR ORTHO PACK Back to Search Results
Catalog Number DYNJ47948B
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Burn(s) (1757)
Event Date 10/03/2018
Event Type  Injury  
Manufacturer Narrative
It was reported that during an arthroscopic shoulder surgery, the cautery pencil signaled in use on the generator despite the rocker-switch on the cautery pencil not activated. Reportedly, this resulted in the patient sustaining "two small full thickness burns distal to the surgical site". These burns were reportedly ellipsed and were repaired through an unknown number of stitches. At the time of the incident, the cautery device was reportedly ready for use on the surgical site and the device was "lying on the patient. " it was added that "at some point during the procedure, the device was indeed left on the patient. " general anesthesia was used and there was no report of any adverse patient consequence and no effect on the patient's stability as a result of the incident. No impact to the staff, the procedure, or the total length of the procedure was reported. Due to the reported medical intervention for the reported burns, this medwatch is being filed. The sample is not available to be returned for evaluation. A root cause could not be determined at this time. No additional information is available. If additional information becomes available, a supplemental medwatch will be filed.
 
Event Description
It was reported that patient sustained burn (distal to the surgical site) from the cautery pencil that signaled in-use on generator despite the rocker-switch on the cautery pencil not activated.
 
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Type of DeviceCAUTERY PENCIL FROM MAJOR ORTHO PACK
Manufacturer (Section D)
MEDLINE INDUSTRIES INC.
three lakes drive
northfield IL 60093
Manufacturer Contact
bermon punzalan
three lakes drive
northfield, IL 60093
2249311514
MDR Report Key8096106
MDR Text Key128101448
Report Number1423395-2018-00059
Device Sequence Number1
Product Code OJH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 11/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberDYNJ47948B
Device Lot Number18HBK660
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/30/2018
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 Treatment Data
Date Received: 11/21/2018 Patient Sequence Number: 1
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