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

Catalog Number	TRS100SB2
Medical Device Problem Codes	Unintended Movement (3026); Sharp Edges (4013)
Health Effect - Clinical Code	Liver Laceration(s) (1955)
Date of Event	07/15/2024
Type of Reportable Event	Serious Injury
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
This complaint was created by the finding of maude report number 19852413.The current complaint database has been researched for this event and there were no findings.The report was found to be written against the trs100sb2, anchor tissue retrieval system for the reported event date of 15jul2024.This was reported as a product problem not an adverse event; however, the report states: ¿the pouch retrieval bag was used to retrieve the gallbladder.Once bag was deployed the metal claps tore through bag and lacerated pt's liver.¿.Further assessment is not possible as the account and contact information for this report are unknown.This report is being raised due to the reported injury of liver laceration to the patient.
Event or Problem Description
This complaint was created by the finding of maude report number: (b)(4).The current complaint database has been researched for this event and there were no findings.The report was found to be written against the trs100sb2, anchor tissue retrieval system for the reported event date of 15jul2024.This was reported as a product problem not an adverse event; however, the report states: ¿the pouch retrieval bag was used to retrieve the gallbladder.Once bag was deployed the metal claps tore through bag and lacerated pt's liver.¿.Further assessment is not possible as the account and contact information for this report are unknown.This report is being raised due to the reported injury of liver laceration to the patient.
Additional Manufacturer Narrative
The device will not be returned, and no photographic evidence was provided.Therefore, a device malfunction 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 2-year lot history review shows a total of 1 device for the reported lot number and failure mode.A two-year review of complaint history revealed there has been a total of seven reports, regarding seven 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 deploy or retract the anchor¿ tissue retrieval system¿ while the distal end of introducer remains inside a trocar as it may adversely affect performance.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.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: beth madeline ; 11311 concept blvd; largo, FL 33773 ; 7274708358
• MDR Report Key: 20199674
• Report Number: 3007305485-2024-00133
• Device Sequence Number: 6879757
• Product Code: GCJ
• UDI-Device Identifier: 20653405986109
• UDI-Public: (01)20653405986109(17)270314(10)202403145
• Combination Product (Y/N): N
• 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
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2024

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: TRS100SB2
• Device Lot Number: 202403145
• 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: 09/04/2024
• Supplement Date Received by Manufacturer: 10/03/2024
• Initial Report FDA Received Date: 09/12/2024
• Supplement Report FDA Received Date: 10/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2024
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 38 YR
• Patient Sex: Male
• Patient Weight: 95 KG
• Patient Ethnicity: Hispanic
• Patient Race: White