MAUDE Adverse Event Report: COVIDIEN; CAUTERY TIP IN MAJOR PACK

Catalog Number DYNJ0429286K

Device Problem Defective Component (2292)

Patient Problem Bowel Burn (1756)

Event Date 04/18/2019

Event Type  Injury  

Manufacturer Narrative

It was initially reported that a defect in the insulation of the long cautery tip (from the custom surgical tray) burned the patient's bowel.Per report, this bowel burn created a tear that required stitching.Despite good faith efforts to obtain additional information, the reporting facility was unable or unwilling to provide any further patient, product, or procedural details.The patient involved in this incident is reportedly stable at this time.Due to the reported event and required medical intervention, this medwatch is being filed.The sample was returned for evaluation and the complaint was confirmed.The manufacturer of the long cautery tip has been notified of this incident.A definitive 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 a defect in the insulation of the long cautery tip (from custom surgical tray) resulted in a burn to the patient's bowel.

• Type of Device: CAUTERY TIP IN MAJOR PACK
• Manufacturer (Section D): COVIDIEN; 710 medtronic parkway; minneapolis MN 55432 5604
• Manufacturer Contact: bermon punzalan ; three lakes drive; northfield, IL 60093
• MDR Report Key: 8620167
• MDR Text Key: 145404412
• Report Number: 1423395-2019-00019
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DYNJ0429286K
• Device Lot Number: 19AKA572
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2019
• Date Manufacturer Received: 04/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention