MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; CAUTERY PENCIL IN SHOULDER PACK KIT

Catalog Number DYNJ57165C

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 04/06/2020

Event Type  malfunction  

Manufacturer Narrative

It was reported that during a right shoulder arthroscopy.The surgeon laid the electrocautery pencil down on an unspecified body part of the patient and the device continued to cauterize while in contact with the patient's skin.The patient required a dressing to the burn area prior to being taken to post anesthesia care unit.No further report of medical intervention was indicated.Patient was discharged to home and is said to be "in good spirits" following the post-operative call.No impact to the procedure was reported to the manufacturer.The sample has not been returned for evaluation.Due to the report of a burn, this medwatch is being filed.If additional information becomes available, a supplemental medwatch will be filed.

Event Description

It was reported a cautery pencil malfunctioned during a right shoulder arthroscopy.The surgeon laid the pencil down and the device continued to cauterize while in contact with the patient's skin.

• Type of Device: CAUTERY PENCIL IN SHOULDER PACK KIT
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield, il
• Manufacturer Contact: teresa maynard ; three lakes drive; northfield, il ; 9311514
• MDR Report Key: 9993490
• MDR Text Key: 190774162
• Report Number: 1423395-2020-00008
• Device Sequence Number: 1
• Product Code: OJH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DYNJ57165C
• Device Lot Number: 19KBG198
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/07/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 121