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

Model Number	TRS080
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint is inconclusive.The device will not be returned for evaluation and no photographic evidence was provided.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.(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 ensure patient safety.
Event or Problem Description
Information was received via (b)(6) incident # - (b)(4).It was reported that the trs080, anchor bag was used in a cholecystectomy on (b)(6) 2019.It was introduced into the abdomen to retrieve the gall bladder (this is normal practice) the gall bladder was placed in the retrieval bag with a 2x2 swab again (normal practice).As the surgeon went to pull on the string of the retrieval bag to bring it out via the port hole the upper part of the bag completely came away from the bottom part.Additional information was requested but none was received.There was no reported patient injury or impact.This report is being raised based on device malfunction with potential for injury upon reoccurrence.

• 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: 8624013
• Report Number: 3007305485-2019-00157
• Device Sequence Number: 19397301
• Product Code: GCJ
• UDI-Device Identifier: 00612376000036
• UDI-Public: (01)00612376000036(17)210601(10)19B8T
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K091930
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/20/2019

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: 06/01/2021
• Device Model Number: TRS080
• Device Catalogue Number: TRS080
• Device Lot Number: 19B8T
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2019
• Initial Report FDA Received Date: 05/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1