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 Split, Cut or Torn (4008)
Health Effect - Clinical Code	Skin Disorders (4543)
Date of Event	06/23/2025
Type of Reportable Event	Serious Injury
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 per regulatory requirements to help ensure patient safety.H3 other text: device not yet received.
Event or Problem Description
This complaint was created due to the receipt of a medwatch report (mw5172233) received on 17jul25.A search of the complaint system has not found a complaint reported for this device during this timeframe.The report was found to be written against the trs-robo-8, anchor tissue retrieval system.The incident occurred on (b)(6) 2025.The report states that ¿retrieval bag ripped open on the bottom seam while being deployed to remove gallbladder.A small cutdown and extra time was needed to retrieve the gallbladder.¿ per further assessment, it was reported that "port site incision was slightly extended to remove gallbladder." the retrieval bag did not fragment.¿ the patient's current condition was reported as "i am unaware of any issues" and there was no extended hospitalization required.This report is being raised due to the reported injury of incision site slightly extended.
Event or Problem Description
This complaint was created due to the receipt of a medwatch report (mw5172233) received on 17jul2025.A search of the complaint system has not found a complaint reported for this device during this timeframe.The report was found to be written against the trs-robo-8, anchor tissue retrieval system.The incident occurred on 23jun25.The report states that ¿retrieval bag ripped open on the bottom seam while being deployed to remove gallbladder.A small cutdown and extra time was needed to retrieve the gallbladder.¿ per further assessment it was reported that "port site incision was slightly extended to remove gallbladder." the retrieval bag did not fragment.¿ the patient's current condition was reported as "i am unaware of any issues" and there was no extended hospitalization required.This report is being raised due to the reported injury of incision site slightly extended.
Additional Manufacturer Narrative
Examination of returned used device trs-robo-8 found that there was a hole in the bottom of the retrieval bag.Note that the steel arms on the handle were bent outwards.Root cause cannot be determined, however, based upon the ifu; a possible cause of this event could be using sharp and electrosurgical devices that cause the bag to rip.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 (b)(4) reports, regarding (b)(4) 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: 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.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: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 22664651
• Report Number: 3007305485-2025-00122
• Device Sequence Number: 19762067
• Product Code: GCJ
• UDI-Device Identifier: 20653405986147
• UDI-Public: (01)20653405986147(17)280205(10)202502054
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K172940
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: TRS-ROBO-8
• Device Lot Number: 202502054
• 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: 07/17/2025
• Supplement Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 08/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 97 KG
• Patient Ethnicity: Non Hispanic