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

Model Number	TRS175SB2
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported device has been returned to conmed; however, the evaluation of the device has not been completed.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.
Event or Problem Description
The customer reported that the device, trs175sb2, ancr tissue retrieval system, 15mm, 1200ml (3/bx), was being used during a laparoscopic nephrectomy procedure on (b)(6) 2023 when it was reported, ¿the surgeon inserted large 15mm bag into the patient to retrieve a very large kidney specimen.The specimen was so large that inserting it into the bag caused significant bending to the neck of the bag itself.Ultimately the specimen proved to be too large, so the bag was removed from the patient.Only after the specimen was removed through a larger incision was it discovered that a metal piece of the bag had come loose and fallen into the abdominal cavity of the patient.The surgeon only noticed it after doing a final sweep of the patient's abdominal cavity with the endoscope right before closure of the remaining laparoscopic ports.The piece was removed from the patient.The lunch relief circulating rn bent another 15mm bag off the field and it broke in the same way, releasing a small metal piece.The patient involved did not sustain and harm, nor delay in care.¿.A series of assessment questions were sent and it was reported by the customer,¿ the specimen was never able to enter the bag completely so the bag method was abandoned, and a larger incision was made using a medium sized alexis wound protector.The specimen was removed by hand through the opening.When that incision was closed, we went back in with the endoscope and retrieved the broken piece with an endo grasper.¿ the device did fragment but it was retrieved with a endo grasper instrument.The procedure was completed with no report of a delay.There was no report of patient or user impact, but medical intervention did occur because the incision was made to be larger.There were no reports of an extended hospital stay for the patient.This report is being raised on the basis of injury due to the report of the incision having to be made larger for procedure completion.
Additional Manufacturer Narrative
Reported event ¿specimen proved to be too large, so the bag was removed from the patient.Only after the specimen was removed through a larger incision was it discovered that a metal piece of the bag had come loose and fallen into the abdominal cavity of the patient¿ was confirmed.Received one trs175sb2 in opened original package.Lot number was verified.Performed a visual inspection, the complaint was confirmed.The retrieval bag came dissembled from the device.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.(b)(4).Per the instructions for use, the user is advised the following: 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.
Event or Problem Description
The customer reported that the device, trs175sb2, ancr tissue retrieval system, 15mm, 1200ml (3/bx), was being used during a laparoscopic nephrectomy procedure on (b)(6) 2023 when it was reported, ¿the surgeon inserted large 15mm bag into the patient to retrieve a very large kidney specimen.The specimen was so large that inserting it into the bag caused significant bending to the neck of the bag itself.Ultimately the specimen proved to be too large, so the bag was removed from the patient.Only after the specimen was removed through a larger incision was it discovered that a metal piece of the bag had come loose and fallen into the abdominal cavity of the patient.The surgeon only noticed it after doing a final sweep of the patient's abdominal cavity with the endoscope right before closure of the remaining laparoscopic ports.The piece was removed from the patient.The lunch relief circulating rn bent another 15mm bag off the field and it broke in the same way, releasing a small metal piece.The patient involved did not sustain and harm, nor delay in care.¿.A series of assessment questions were sent and it was reported by the customer,¿ the specimen was never able to enter the bag completely so the bag method was abandoned, and a larger incision was made using a medium sized alexis wound protector.The specimen was removed by hand through the opening.When that incision was closed, we went back in with the endoscope and retrieved the broken piece with an endo grasper.¿ the device did fragment but it was retrieved with a endo grasper instrument.The procedure was completed with no report of a delay.There was no report of patient or user impact, but medical intervention did occur because the incision was made to be larger.There were no reports of an extended hospital stay for the patient.This report is being raised on the basis of injury due to the report of the incision having to be made larger for procedure completion.

• 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: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 16744806
• Report Number: 3007305485-2023-00082
• Device Sequence Number: 6539597
• Product Code: GCJ
• UDI-Device Identifier: 20653405986116
• UDI-Public: (01)20653405986116(17)251108(10)202211094
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 05/30/2023

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 Expiration Date: 11/08/2025
• Device Model Number: TRS175SB2
• Device Catalogue Number: TRS175SB2
• Device Lot Number: 202211094
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2023
• Supplement Date Received by Manufacturer: 05/30/2023
• Initial Report FDA Received Date: 04/14/2023
• Supplement Report FDA Received Date: 05/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic