MAUDE Adverse Event Report: AESCULAP INC MONOPOLAR CABLE W/LG PIN, 10 FEET; HIGH FREQUENCY TECHNOLOGY

Model Number US354

Device Problem Defective Component (2292)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/17/2017

Event Type  malfunction  

Manufacturer Narrative

A retrospective review of potential serious injury complaints was performed.This mdr was identified and filed as part of the review activities.Supplier: (b)(4).Supplier investigation: without the lot number, we cannot say for sure the age of this product, but it does appear to have been used a significant amount based on the wearing of the connectors and the fading in color of the cord jacket.Based on the breakage in the cord, my belief is that at least the distal end of the cord was removed from the instrument by tugging on the cord and not by pulling the connector.Over time as the cord is removed this way, the wire strands inside the cord jacket will fray and break, which was likely the cause of the "interference" noted in the complaint.The jacket breaking and distal connector breaking off appear to be a result of the same issue as the jacket will eventually break along with the wires.Disposition: no action required.

Event Description

It was reported that there was an issue with the monopolar cable.During a laparoscopic procedure, there was interference noted from the bovie machine (electrocautery surgical unit).During the time that the power cord was being switched, the distal tip "popped and flew off." the malfunction caused a surgical delay of 15 minutes.There was no patient harm.

• Brand Name: MONOPOLAR CABLE W/LG PIN, 10 FEET
• Type of Device: HIGH FREQUENCY TECHNOLOGY
• Manufacturer (Section D): AESCULAP INC; 3773 corporate parkway; center valley, pa
• Manufacturer (Section G): AESCULAP INC; 3773 corporate parkway; center valley, pa
• Manufacturer Contact: lindsay chromiak ; 3773 corporate parkway; center valley, pa
• MDR Report Key: 10015564
• MDR Text Key: 189570888
• Report Number: 2916714-2020-00156
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K913514
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/30/2020

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: 09/14/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/17/2016
• Initial Date FDA Received: 04/30/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1