MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT ANCHOR TISSUE RETRIEVAL SYSTEM , TRS175SB2; SPECIMEN BAG

Model Number TRS175SB2

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem Blood Loss (2597)

Event Date 07/12/2019

Event Type  Injury  

Manufacturer Narrative

Complaint is confirmed.Received one trs175sb2 in opened original packaging.Lot number was confirmed.Performed a visual inspection of the device, the string was wrapped multiple times around the plunger creating tension.The metal prongs were protruding out of the sides of the retrieval bag.Performed a functional inspection, the white inner plunger was difficult to maneuver in and out.Without disconnecting the string and retrieval bag you could not pull the white plunger out from the purple shaft.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution were found to have met all specifications prior to shipment.This is the only complaint for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been 9 complaints regarding 9 devices for this device family and failure mode.During the same time frame 385,738 devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed, the rate of failure would be.00002 per the instructions for use, the user is advised the following; only physicians trained in the techniques of laparoscopic or minimally invasive surgery and the use of retrieval bags to remove tissue should use the product.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 trs175sb2, " was deployed and the metal distal tip of the bag was exposed on both sides.The staff reported that the metal tip caused the patient to bleed from the incision site more than usual." the procedure performed on (b)(6) 2019 was completed using another of the same specimen bag.Cautery was used to stop the bleeding.A larger incision to remove the device was not needed.This report is being raised due to patient injury.

• Brand Name: ANCHOR TISSUE RETRIEVAL SYSTEM , TRS175SB2
• 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: 8864026
• MDR Text Key: 153381802
• Report Number: 3007305485-2019-00281
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 20653405986116
• UDI-Public: (01)20653405986116(17)210919(10)201809209
• 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: 08/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/19/2021
• Device Model Number: TRS175SB2
• Device Catalogue Number: TRS175SB2
• Device Lot Number: 201809209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2019
• Date Manufacturer Received: 07/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2018
• 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
• Patient Outcome(s): Other