MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT TISSUE RETRIEVAL SYSTEM 10MM; SPECIMEN BAG

Model Number TRS100SB2

Device Problem Material Puncture/Hole (1504)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/15/2019

Event Type  malfunction  

Manufacturer Narrative

Received one trs100sb2 in opened unoriginal packaging.Lot number could not be verified.Performed a visual inspection, the complaint is confirmed.The laceration has a cut appearance as though the device got caught on a sharp object.A two-year lot history review was conducted using the possible lot number provided and found no other similar complaints for this lot number and failure mode.A dhr review of possible lot number provided found no abnormalities that would contribute to this issue.A two-year review of complaint history revealed there has been 16 complaints regarding 19 devices for this device family and failure mode.During the same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed, the rate of failure would be (b)(4).Per the instructions for use, the user is advised the following; 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.

Event Description

The conmed representative reported on behalf of the facility that the trs100sb2, tissue retrieval system, had an l shaped tear in the bag when the surgical team went to put the specimen in it during a hysterectomy on (b)(6) 2019.The bag was only deployed once, it is unknown if there was any resistance deploying the bag.The bag was being removed through the port with the assistance of a kocher clamp.It is unknown if the bag was inspected prior to use.The procedure was completed with a few minute delay to get another specimen bag.A lot number was provided on the complaint, however, it could not be verified that it was the lot number that was used in the procedure.There was no reported patient injury or impact.This report is being raised based on device malfunction with potential for injury upon reoccurrence.

• Brand Name: TISSUE RETRIEVAL SYSTEM 10MM
• Type of Device: SPECIMEN BAG
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT; alejandro dumas ave, 11321; complejo industrial chihuahua; 31136 ; MX 31136
• Manufacturer (Section G): CONSOLIDATED MEDICAL EQUIPMENT; alejandro dumas ave, 11321; complejo industrial chihuahua; 31136 ; MX 31136
• Manufacturer Contact: melanie lannon ; 11311 concept boulevard; largo, FL 33773 ; 7273995209
• MDR Report Key: 9418806
• MDR Text Key: 206370788
• Report Number: 3007305485-2019-00403
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 20653405986109
• UDI-Public: (01)20653405986109(17)220919(10)201909204
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172940
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/19/2022
• Device Model Number: TRS100SB2
• Device Catalogue Number: TRS100SB2
• Device Lot Number: 201909204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2019
• Date Manufacturer Received: 11/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1