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	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2024
Type of Reportable Event	Malfunction
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 for trends through the complaint system to assure patient safety.
Event or Problem Description
The customer reported that the device, trs-robo-8, anchor tissue retrieval system, was being used during an unknown procedure on 27may24 when it was reported, ¿the bag has ripped when removed from the patient leaving parts of the bag inside the patient.¿.There was no report of injury, medical intervention, or hospitalization for the patient or user.Further questioning found that ¿the bags are breaking and dropping inside the patient when the surgeons attempts to pull them out through the port hole.The item was retrieved.¿ the procedure was completed with a 5-10-minute delay using another alternate device.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Event or Problem Description
The customer reported that the device, trs-robo-8, anchor tissue retrieval system, was being used during an unknown procedure on (b)(6) 2024 when it was reported, ¿the bag has ripped when removed from the patient leaving parts of the bag inside the patient.¿ there was no report of injury, medical intervention, or hospitalization for the patient or user.Further questioning found that ¿the bags are breaking and dropping inside the patient when the surgeons attempts to pull them out through the port hole.The item was retrieved.¿ the procedure was completed with a 5-10-minute delay using another alternate device.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The device will not be returned and no photographic evidence was provided therefore, a device malfunction cannot be verified.A device history record review found a non-conformance however it was not related to the manufacture the product.A 2 year lot history review shows a total of 3 devices for the reported lot number and failure mode.A two-year review of complaint history revealed there has been a total of 22 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 to 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 for trends through the complaint system to assure 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: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 20143877
• Report Number: 3007305485-2024-00126
• Device Sequence Number: 4236621
• Product Code: GCJ
• UDI-Device Identifier: 20653405986147
• UDI-Public: (01)20653405986147(17)270527(10)202405274
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K172940
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2024

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: TRS-ROBO-8
• Device Lot Number: 202405274
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2024
• Supplement Date Received by Manufacturer: 09/24/2024
• Initial Report FDA Received Date: 09/05/2024
• Supplement Report FDA Received Date: 10/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic