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

Catalog Number	DYNJ47948B
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	10/03/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.

• Common Device Name: CAUTERY PENCIL FROM MAJOR ORTHO PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 8096106
• Report Number: 1423395-2018-00059
• Device Sequence Number: 11449374
• Product Code: OJH
• UDI-Device Identifier: 10889942650231
• UDI-Public: 10889942650231
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 11/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: DYNJ47948B
• Device Lot Number: 18HBK660
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/30/2018
• Initial Report FDA Received Date: 11/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Weight: 138