MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY TRS, 15MM (3/BX); LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	TRS175SB2
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The sales representative reported on behalf of the customer that the device, (b)(4), was being used on (b)(6) 2021 during an unknown procedure and the ¿ring holding pouch broke leaving a piece in the abdomen that had to be removed with a grasper.¿ the procedure was completed with a 10 minute delay.There no was injury or impact to the patient.Further assessment was sent; however, no more information was available.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The device will not be returned for evaluation and no photographic evidence has been provided; therefore, the reported event cannot be verified.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 was 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 a total of 24 complaints, regarding 37 devices, for this device family and failure mode.During this same time frame (b)(4) 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 (b)(4).Per the instructions for use, the user is advised the following: care should be taken when using sharp and electro-surgical devices.Note the size of the trocar cannula when removing a specimen through the trocar cannula and seal system.If required, enlarge the port site to aid removal of the anchor tissue retrieval system.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: TRS, 15MM (3/BX)
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• MDR Report Key: 12386257
• Report Number: 3007305485-2021-00337
• Device Sequence Number: 4892665
• Product Code: GCJ
• UDI-Device Identifier: 20653405986116
• UDI-Public: (01)20653405986116(17)240318(10)202103194
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K172940
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/30/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/18/2024
• Device Model Number: TRS175SB2
• Device Catalogue Number: TRS175SB2
• Device Lot Number: 202103194
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2021
• Initial Report FDA Received Date: 08/30/2021
• Patient Sequence Number: 1