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

Catalog Number	TRS-ROBO-8
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	04/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that the trs-robo-8, anchor tissue retrieval system device was being used during a laparoscopic gallbladder removal procedure on (b)(6) 2025.When it was reported, ¿this is now the 4th bag that the doctor has ripped.It keeps ripping at the bottom seam.¿ further assessment questioning found that the device did not fragment or fall into the surgical site.The specimen did however, fall back into the patient and cause contamination.The procedure was completed and there was no report of medical or surgical intervention.This report is being raised due to the reported injury of the patient¿s abdomen being contaminated from the specimen rupturing and falling back into the patient.
Additional Manufacturer Narrative
The device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.A supplemental and final report will be filed following the completion of the complaint investigation.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
The customer reported that the trs-robo-8, anchor tissue retrieval system device, was being used during a laparoscopic gallbladder removal procedure on (b)(6) 2025 when it was reported, ¿this is now the 4th bag that the doctor has ripped.It keeps ripping at the bottom seam.¿ further assessment questioning found that the device did not fragment or fall into the surgical site.The specimen did however, fall back into the patient and cause contamination.The procedure was completed and there was no report of medical or surgical intervention.This report is being raised due to the reported injury of the patient¿s abdomen being contaminated from the specimen rupturing and falling back into the patient.
Additional Manufacturer Narrative
Reported event of ¿ripping at the bottom seam¿ was inconclusive.Neither the device nor photographic evidence was 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.A two-year lot history review shows a total of (b)(4) devices for this lot number and failure mode; however, one was confirmed.A two-year review of complaint history revealed there has been a total of (b)(4) complaints, regarding 52 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 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 by conmed.We will continue to monitor per regulatory requirements to help ensure patient safety.

• 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: 22034461
• Report Number: 3007305485-2025-00087
• Device Sequence Number: 18337522
• Product Code: GCJ
• UDI-Device Identifier: 20653405986147
• UDI-Public: (01)20653405986147(17)280120(10)202501204
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K172940
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: TRS-ROBO-8
• Device Lot Number: 202501204
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2025
• Supplement Date Received by Manufacturer: 06/11/2025
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic