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

Catalog Number	TRS100SB2
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2024
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
A customer reported that the trs100sb2, ancr tissue retrieval system, 10mm, 175ml (5/bx) device was being used during a lap chole procedure on 03jul24, and ¿metal arms did not deploy correctly pierced through into bag¿, and the customer noted ¿potential adverse outcome¿.Follow-up assessment found that when the event occurred, the device was not in contact with the patient and the specimen was not in the bag; the bag did not fragment; no specimen content and no device component or fragment fell into the surgical site.There was a delay of 15 minutes.There was no adverse outcome, injury, medical/surgical intervention or extended hospital stay required for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Received one trs100sb2 in opened original package.Lot number was verified.Performed a visual inspection, the retrieval bag was not returned for evaluation.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 this lot number and failure mode.A two-year review of complaint history revealed there has been a total of 9 reports, regarding 9 devices, for this device family and failure mode.During this same time frame 777,333 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 0.00001.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.
Event or Problem Description
A customer reported that the trs100sb2, ancr tissue retrieval system, 10mm, 175ml (5/bx) device was being used during a lap chole procedure on (b)(6)2024, and ¿metal arms did not deploy correctly pierced through into bag¿, and the customer noted ¿potential adverse outcome¿.Follow-up assessment found that when the event occurred, the device was not in contact with the patient and the specimen was not in the bag; the bag did not fragment; no specimen content and no device component or fragment fell into the surgical site.There was a delay of 15 minutes.There was no adverse outcome, injury, medical/surgical intervention or extended hospital stay required 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: beth madeline ; 11311 concept blvd; largo, FL 33773 ; 7274708358
• MDR Report Key: 19860168
• Report Number: 3007305485-2024-00109
• Device Sequence Number: 7374433
• Product Code: GCJ
• UDI-Device Identifier: 20653405986109
• UDI-Public: (01)20653405986109(17)270121(10)202401225
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2024

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: 202401225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2024
• Supplement Date Received by Manufacturer: 08/27/2024
• Initial Report FDA Received Date: 07/30/2024
• Supplement Report FDA Received Date: 09/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic