MAUDE Adverse Event Report: ANCHOR PRODUCTS COMPANY ANCHOR TISSUE RETRIEVAL SYSTEM; SPECIMEN BAG

Model Number	TRS070
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint is inconclusive.The device will not be returned for evaluation however a photograph of the device was provided.The photograph shows a hole in the bag of the device however it cannot be determined if the missing piece remained in the patient.Additionally, review of correspondence indicated the device was repeatedly inserted/ withdrawn from the trocar; it appears that the bag was not properly folded as a documented procedure was provided specifying how the device is to be folded for insertion for future procedures.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 were 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.A two-year review of complaint history revealed there has been (b)(4) complaints regarding (b)(4) devices for this device family and failure mode.During the same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed, the rate of failure would be (b)(4).Per the instructions for use, the user is advised the following: only physicians trained in the techniques of laparoscopic or minimally invasive surgery and the use of retrieval bags to remove tissue should use the product.Care should be taken when using sharp and electrosurgical devices.Note the size of the trocar when removing a specimen through the trocar cannula and seal system.If required, enlarge the port site to aid in the removal of the anchor tissue retrieval system.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The distributor reported on behalf of the customer that the trs070, specimen bag, was used during a cholecystectomy on (b)(6) 2019 and was found to have a hole in after the specimen was retrieved.The surgical team is unsure if the fragment remains in the patient or if it was removed when the suction and irrigation was used.This report is being raised as a patient injury due to the unknown location of the specimen bag fragment and the possibility that it remained in the patient.

• Brand Name: ANCHOR TISSUE RETRIEVAL SYSTEM
• Common Device Name: SPECIMEN BAG
• Manufacturer (Section D): ANCHOR PRODUCTS COMPANY; 52 official rd; addison IL 60101
• MDR Report Key: 8794443
• Report Number: 3007305485-2019-00229
• Device Sequence Number: 1904838
• Product Code: GCJ
• UDI-Device Identifier: 00612376000050
• UDI-Public: (01)00612376000050(17)201201(10)65C7T
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K172940
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/16/2019

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: 12/01/2020
• Device Model Number: TRS070
• Device Catalogue Number: TRS070
• Device Lot Number: 65C7T
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2019
• Initial Report FDA Received Date: 07/16/2019
• 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