MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY ANCHOR TISSUE RETRIEVAL SYSTEM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	TRS100SB2
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2024
Type of Reportable Event	Malfunction
Additional 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.We will continue to monitor for trends through the complaint system to assure patient safety.H3 other text: device not yet received.
Event or Problem Description
The customer reported that the trs100sb2, anchor tissue retrieval system, device was being used on (b)(6) 2024 during a laparoscopic roux en y gastric bypass procedure when it was reported ¿when extracting the fired 25mm eea intraluminal stapler, the endocatch (anchor tissue retrieval system by conmed) malfunctioned.The specimen bag that was supposed to protect the15mm port site (abdominal wall tissue) from small bowel contents (scant amount) did not seal properly and had come undone during the extraction.As a result, the patient tissue (abdominal wall tissue) was exposed.A mixture of iodine and saline was irrigated to the site as infection prevention.¿.Further assessment questioning found that the device did not fragment or fall into the surgical site."no apparent harm - reached patient/person, inconvenient." the procedure was completed with the use of an alternate device.There was no report of injury, medical intervention, or extended hospitalization for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Received one used trs100sb2, anchor tissue retrieval system in opened original container.Lot number returned was different than reported (202401305).The device was returned without the bag; however, there is visible physical damage to the shaft and the prongs appear to be slightly bent out of original shape.The damage appears to have occurred during use or extraction of the specimen.If significant force was used to remove the specimen, then it is likely that the device was damaged at that time.However, the bag was not received; therefore the report of the bag issue 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.A two-year lot history review shows a total of 1 device for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of 21 complaints, regarding 23 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 that 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.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.Care should be taken when using sharp and electro-surgical devices.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
The customer reported that the trs100sb2, anchor tissue retrieval system, device was being used on (b)(6) 2024 during a laparoscopic roux en y gastric bypass procedure when it was reported ¿when extracting the fired 25mm eea intraluminal stapler, the endocatch (anchor tissue retrieval system by conmed) malfunctioned.The specimen bag that was supposed to protect the15mm port site (abdominal wall tissue) from small bowel contents (scant amount) did not seal properly and had come undone during the extraction.As a result, the patient tissue (abdominal wall tissue) was exposed.A mixture of iodine and saline was irrigated to the site as infection prevention.¿.Further assessment questioning found that the device did not fragment or fall into the surgical site."no apparent harm - reached patient/person, inconvenient." the procedure was completed with the use of an alternate device.There was no report of injury, medical intervention, or extended hospitalization for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: ANCHOR TISSUE RETRIEVAL SYSTEM
• 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
• Manufacturer (Section G): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• Manufacturer Contact: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 20522487
• Report Number: 3007305485-2024-00155
• Device Sequence Number: 9171022
• Product Code: GCJ
• UDI-Device Identifier: 20653405986109
• UDI-Public: (01)20653405986109(17)270129(10)202401305
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K172940
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2024

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 Catalogue Number: TRS100SB2
• Device Lot Number: 202401305
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2024
• Supplement Date Received by Manufacturer: 11/22/2024
• Initial Report FDA Received Date: 10/24/2024
• Supplement Report FDA Received Date: 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic