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

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.

• Type of Device: CAUTERY 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 Key: 8096106
• MDR Text Key: 128101448
• Report Number: 1423395-2018-00059
• Device Sequence Number: 1
• Product Code: OJH
• UDI-Device Identifier: 10889942650231
• UDI-Public: 10889942650231
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 11/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DYNJ47948B
• Device Lot Number: 18HBK660
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/30/2018
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 138