MAUDE Adverse Event Report: AESCULAP INC MONOPOLAR CABLE W/LG PIN, 10 FEET; LAPAROSCOPIC SURGERY

Model Number US354

Device Problem Disconnection (1171)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/29/2020

Event Type  malfunction  

Manufacturer Narrative

If additional information or investigation results become available, a supplemental mdr will be provided.

Event Description

It was reported that the monopolar cable w/lg pin, 10 feet malfunctioned during cauterization in a procedure.It was noted that the device had been set to 40, a setting typically used by the surgeon without issue.The cord then "burned off "(popped off) and fell to the ground.The cord landed on the ground away from the surgical field.A back-up device was readily available and was used to successfully complete the procedure.There was no additional medical intervention, no harm to the patient and no surgical delay due to the reported event.

Manufacturer Narrative

E- reporter updated.Mdr format corrected (manufacturer report and not an importer report).If additional information or investigation results become available, a supplemental report will be provided.

Event Description

Additional information was received via mw5097096: during the procedure, there was a break in the monopolar bovie cord.This was approximately 2 inches from the end that connects the cord to the hook cautery.The cord was hot to the touch and glowed orange.There was no patient or employee injury.("serious injury" had been checked off on the form, but an injury nor intervention were noted).

Manufacturer Narrative

The device was returned for evaluation; a lot number was not provided nor visible.Visual inspection was performed.The instrument connector had completely detached from the remainder of the cord.Portions of the cord jacket were stripped and the entire wire within the cord was found to be oxidized (aged and brittle).The level of oxidation increased the resistance of the wire to a degree that caused a joule heating event that resulted in the insulation melting.The lot number of the cord was not provided.However, considering the condition in which it arrived, the cord was likely being used long past its recommended life cycle.There is no evidence to suggest any defect in design, material or workmanship.The cord was used beyond its life expectancy which caused it to fail.

• Brand Name: MONOPOLAR CABLE W/LG PIN, 10 FEET
• Type of Device: LAPAROSCOPIC SURGERY
• Manufacturer (Section D): AESCULAP INC; 3773 corporate parkway; center valley PA 18034
• MDR Report Key: 10742119
• MDR Text Key: 213446945
• Report Number: 2916714-2020-00596
• Device Sequence Number: 1
• Product Code: HIM
• UDI-Device Identifier: 04046964582820
• UDI-Public: 4046964582820
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup,Followup
• Report Date: 10/27/2020,07/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: US354
• Device Catalogue Number: US354
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2020
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/27/2020
• Distributor Facility Aware Date: 09/30/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/27/2020
• Supplement Dates Manufacturer Received: 10/21/2020; 12/11/2020
• Supplement Dates FDA Received: 11/13/2020; 07/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ELECTROCAUTERY UNIT