MAUDE Adverse Event Report: CONMED CORPORATION; CAUTERY TIP IN THORACOTOMY PACK

Catalog Number DYNJ60884

Device Problem Device Slipped (1584)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/27/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported that the cautery tip (from custom surgical tray) was slightly smaller in diameter.A red rubber catheter (not from custom surgical tray) was reportedly used on the cautery tip to "provide insulation in sensitive lung tissue." per report, the red rubber catheter slipped off the cautery tip and had to be retrieved from the patient by the surgeon.Reportedly, there was "no harm to patient." despite good faith efforts to obtain additional information, the reporting facility was unable or unwilling to provide any further patient, product, procedural or event details.Due to the reported medical intervention of retrieving the red rubber catheter that fell off into patient during use with the cautery device, this medwatch is being filed.The cautery tip is not available to be returned for evaluation.A definitive root cause for the reported issue with the cautery tip could not be determined at this time.Of note, using a red rubber catheter to provide insulation is off-label.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.

Event Description

It was reported that the cautery tip was slightly smaller in diameter.A red rubber catheter was used on the cautery tip to provide insulation and red rubber catheter slipped off into surgical site and had to be retrieved from the patient by the surgeon.

• Type of Device: CAUTERY TIP IN THORACOTOMY PACK
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502
• Manufacturer Contact: bermon punzalan ; three lakes drive; northfield, IL 60093
• MDR Report Key: 9104670
• MDR Text Key: 170109660
• Report Number: 1423395-2019-00035
• 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,user f
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DYNJ60884
• Device Lot Number: 19PBB688
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/29/2019
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention