MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT TIS RET SYS 10MM, 180ML(5/BX); LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number TRS100SB2

Device Problem Mechanical Problem (1384)

Patient Problem Laceration(s) (1946)

Event Date 11/30/2019

Event Type  Injury  

Manufacturer Narrative

The reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The customer reported that the device, trs100sb2, was being used during a laparoscopic left ovarian cystectomy and oophorectomy; exploratory laparotomy on (b)(6) 2019 when the metal frame of the device was exposed and cause a laceration of the patient abdomen wall.Further assessment information was requested from the reporter; however, the reporter has stated that no further information is available.This report is being raised on the basis of injury due to patient receiving lacerations on the abdomen wall.

Manufacturer Narrative

Received one trs100sb2 in unoriginal packaging.Lot number could not be verified.Performed a visual inspection, the prongs were slightly bent and the bag was received unattached from the prongs.Performed a functional inspection, the device functioned as intended.This issue will continue to be monitored through the complaint system to assure patient safety.

Manufacturer Narrative

To date, the reported device has not been returned to conmed for evaluation.Should the device be returned an evaluation will be performed.Upon completion of the complaint investigation a supplemental and final report will be filed.Otherwise this filing will stand as the final report.The manufacturing documents from the device history record have not been reviewed due to the lot number of the device unkonwn.A two-year review of complaint history revealed there has been a total of 5 complaints, regarding 5 devices, for this device family and failure mode.During this same time frame 462,254 devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be 0.00001.Per the instructions for use, the user is advised the following: warnings: -do not use the anchor tissue retrieval system if resistance is met upon deployment.Improper use of the anchor tissue retrieval system may result in perforation of tissue and subsequent bleeding.Precautions: care should be taken when using sharp and electro-surgical devices.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: TIS RET SYS 10MM, 180ML(5/BX)
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT; alejandro dumas ave, 11321; complejo industrial chihuahua; chihuahua, 31136 ; MX 31136
• MDR Report Key: 9769291
• MDR Text Key: 188823971
• Report Number: 3007305485-2020-00090
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• PMA/PMN Number: K172940
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 06/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: TRS100SB2
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2020
• Date Manufacturer Received: 06/09/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other