MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY ANCR TISSUE RETRIEVAL SYSTEM, 15MM, 1200ML (3/BX); LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	TRS175SB2
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	03/13/2024
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 sales representative reported on behalf of a customer that the trs175sb2, ancr tissue retrieval system, 15mm, 1200ml (3/bx) device was being used on (b)(6) 2024, and ¿doctor was preforming a hysterectomy w/ fibroids.Fibroids were large and needed morcellation prior to removal.Surgeon replaced airseal 8mm port with a 15mm port to place trs175sb2 through the port.When pulling on bag, it snapped completely into 2.¿ follow-up assessment found that "the bottom portion of the bag did fall into the patient.The piece that fell into the patient was retrieved.A robotic arm helped place the fragmented piece into a new bag.The patient and user were not injured." the procedure was completed using a same alternate device and with a reported delay of 15 minutes.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.An airseal, 8 mm port and an airseal, 15 mm port will be listed as a concomitant devices.There are no allegations filed against them.
Additional Manufacturer Narrative
Received one trs175sb2 in opened original packaging.Lot number was verified.Performed a visual inspection, the bag was torn in half.A root cause cannot be determined.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 such occurrence for this lot number and failure mode within the past two years.(b)(4).Per the instructions for use, the user is advised the following: the use of morcellators within the anchor¿ tissue retrieval system¿ by conmed has not been evaluated.The anchor¿ tissue retrieval system¿ by conmed is not recommended for use with power morcellators.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 sales representative reported on behalf of a customer that the trs175sb2, ancr tissue retrieval system, 15mm, 1200ml (3/bx) device was being used on (b)(6) 2024, and "doctor was preforming a hysterectomy w/ fibroids.Fibroids were large and needed morcellation prior to removal.Surgeon replaced airseal 8mm port with a 15mm port to place trs175sb2 through the port.When pulling on bag, it snapped completely into 2".Follow-up assessment found that "the bottom portion of the bag did fall into the patient.The piece that fell into the patient was retrieved.A robotic arm helped place the fragmented piece into a new bag.The patient and user were not injured." the procedure was completed using a same alternate device and with a reported delay of 15 minutes.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.An airseal, 8 mm port and an airseal, 15 mm port will be listed as a concomitant devices.There are no allegations filed against them.

• Brand Name: ANCR TISSUE RETRIEVAL SYSTEM, 15MM, 1200ML (3/BX)
• 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: 19072628
• Report Number: 3007305485-2024-00050
• Device Sequence Number: 11932963
• Product Code: GCJ
• UDI-Device Identifier: 20653405986116
• UDI-Public: (01)20653405986116(17)260314(10)202303154
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2024

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 Expiration Date: 03/14/2026
• Device Catalogue Number: TRS175SB2
• Device Lot Number: 202303154
• 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: 03/13/2024
• Supplement Date Received by Manufacturer: 04/22/2024
• Initial Report FDA Received Date: 04/09/2024
• Supplement Report FDA Received Date: 05/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AIRSEAL 15 MM PORT; AIRSEAL 15 MM PORT; AIRSEAL 8 MM PORT; AIRSEAL 8 MM PORT
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic