Summary of MedSun Reports Describing Problems With Specimen Retrieval Systems
MedSun: Newsletter #60, May 2011

A Specimen Retrieval Bag is a disposable medical device used as a receptacle for the collection and extraction of tissue specimens such as the appendix, gallbladder, ovaries, fibroid tumors, other tissues and calculi during laparoscopic surgical procedures. It consists of a flexible polymer bag and an introducer that fits through a trocar port. This product is part of a specimen retrieval system defined as a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals (21 CFR pt 876.1500) and consists of various rigid or flexible instruments which are inserted into body spaces and may include an optical system for conveying an image to the user’s eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. The classification for this device is class II.

Over the past 2 years, Med Sun has received 11 adverse event reports concerning 13 Specimen Retrieval Bag devices manufactured by Ethicon Endosurgery, Applied Medical, Covidien and Anchor Products Company, Inc. The reports were submitted by 9 hospitals between April 2009 and April 2011.

The reported device problems describe the bag detaching, tearing, or failing to open. When the bag detaches or tears it fails to contain the specimen, this may extend the surgical and anesthesia time for the patient. This also increases the potential for a retained foreign object being left in the body cavity.

The reported device problems were:
• Specimen bag detachment (4)
• Specimen bag tear (4)
• Specimen bag fails to open (2)
• Breakage during use (2)
• Metal prong component breakage (1)

None of the reported events involved a patient death. The patient problem, “possible bowel perforation” was listed was reported in 1 of the 11 reports.

Of the reports that listed patient age, 1 had a patient age listed as less than 21 years and 8 had a patient age listed as greater than 21 years. Of the reports that listed patient gender, a total of 4 reports involved female patients and a total of 5 reports involved male patients.

These Med Sun reports summarized above, in addition to manufacturer, healthcare, and voluntary reports contributed to FDA awareness of the device problems.

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The following 2 recalls are associated with the Specimen Retrieval Bag since April 2009. The MedSun reported events may, or may not, be involved in the recalls listed.

Recall Number: Z-1590-2011
Date Posted: 03/07/2011
Product: Anchor Tissue Retrieval System TRS175SB
Code Information: Code TRS175SB, lots P36N, P38N, P72N, P77N, P90N, P94N, P98N, Q05N, Q06N, Q11N, Q14N, Q24N, Q26N, Q36N and Q43N
Recalling Firm/Manufacturer: Anchor Products Company, Inc
Action: Class II recall. The firm, Anchor, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated December 8, 2010 to all customers. The letter described the product, problem and actions to be taken. The customers were instructed to examine their inventory and return any remaining units to their distributor for replacement; and complete and return the attached ANCHOR RECALL RETURN RESPONSE FORM via fax to (314) 961-4535 or mail to: Progressive Medical, Inc., Attn: Marketing Manager, 11085 Gravois Industrial Court, St. Louis, MO 63128, even if they have no inventory. A representative of Anchor Products then visited each of the direct accounts to help them implement their sub recall of the devices from their customers. For additional information please contact: Vice President, Anchor Products Company at 1-800-543-9124 or 1-630-543-9124; and the distributor at 1-800-969-6331 or 1-314-961-4535
Distribution: Worldwide Distribution (1).

Recall Number: Z-1591-2011
Date Posted: 03/07/2011
Product: Anchor Tissue Retrieval System TRS100SB
Product 1: Anchor Tissue Retrieval System; ETO sterilized, single use disposable device; port size 10 mm, 225 mL capacity; 3 units per box; Manufacturer: Anchor Products Co., 52 Official Rd, Addison, IL 60101 U.S.A.; Ref TRS100SB
Code Information: TRS100SB, lots P05N, P07N, P11N, P13N, P19N, P20N, P23N, P25N, P29N, P30N, P31N, P34N, P37N, P41N, P42N, P43N, P44N, P46N, P47N, P48N, P49N, P51N, P52N, P53N, P55N, P56N, P57N, P58N, P60N, P61N, P66N, P68N, P69N, P71N, P75N, P78N, P85N, P90N, P94N, P94N, P96N, P98N, P99N, Q02N, Q04N, Q05N, Q06N, Q09N, Q11N, Q12N, Q13N, Q14N, Q17N, Q20N, Q23N, Q24N, Q30N, Q31N, Q36N, Q38N, Q41N, Q49N, Q50N and Q65N
Product 2: Anchor Tissue Retrieval System; ETO sterilized, single use disposable device; port size 15 mm, 1550 mL capacity; 3 units per box; Manufacturer: Anchor Products Co., 52 Official Rd, Addison, IL 60101 U.S.A.; Ref TRS175SB
Code Information: TRS175SB, lots P36N, P38N, P72N, P77N, P90N, P94N, P98N, Q05N, Q06N, Q11N, Q14N, Q24N, Q26N, Q36N and Q43N
Recalling Firm/Manufacturer: Anchor Products Company, Inc
Action: Class II recall The firm, Anchor, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated December 8, 2010 to all customers. The letter described the product, problem and actions to be taken. The customers were instructed to examine their inventory and return any remaining units to their distributor for replacement; and complete and return the attached ANCHOR RECALL RETURN RESPONSE FORM via fax to (314) 961-4535 or mail to: Progressive Medical, Inc., Attn: Marketing Manager, 11085 Gravois Industrial Court, St. Louis, MO 63128, even if they have no inventory. A representative of Anchor Products then visited each of the direct accounts to help them implement their subrecall of the devices from their customers. For additional information please contact: Vice President, Anchor Products Company at 1-800-543-9124 or 1-630-543-9124; and the distributor at 1-800-969-6331 or 1-314-961-4535.
Distribution: Worldwide Distribution (2).


MedSun Reports Describing Problems with Specimen Retrieval Systems
DeviceDevice Identifiers (Catalog Nimber, Model Number, Lot Number) Event Description
Ethicon EndoSurgery LLC, Endopouch Retriever 2015-05, A94580P00, G4TA08 A 10 ml endopouch broke into 2 separate pieces while in use. Pieces retrieved, specimen retrieved with no patient injury.
Applied Medical, Inzii Retrieval System NA, CD001,1102568
During laparoscopic cholecystectomy with laparoscopic appendectomy, the retrieval bag broke. Specimens were retained in the bag fragment and were able to be removed. Remaining bag pieces were removed and examined by the surgeon who indicated all pieces had been removed.
Ethicon Endo Surgery, Endopouch Retriever NA, NA, 2014-02
Utilizing an Endopouch retriever bag to remove the gallbladder and stones, the end of the bag "popped off" into the patient. Visualized by a surgical tech at the time of separation. The remaining stones were removed with the other bags. Patient irrigated and suctioned with lactated ringers. Missing portion of bag removed.
Anchor Products Company, Laparoscopic Tissue Retrieval System TRS175SB, NA, Q06N
During a laparoscopic splenectomy, one of the two metal prongs from the tissue retrieval system broke off inside the patient and was retrieved. Small lacerations were noted on the abdominal wall peritoneum that appear to be caused by the broken end of the prong. Each of the two metal prongs has a hole for a swivel pin. The one prong broke at sides of this hole.
Ethicon Endo Surgery, Endopouch Retriever NA, NA, G4R94V
The endopouch retriever was being used to retrieve the specimen (ovary) from the abdomen when the bag tore/failed (apparently after the opening of the bag was delivered through the abdominal wall). At the same time a perforation of the bowel (rectosigmoid colon) was also detected. It is unclear if the two are at all related.
Applied Medical, Inzii Retrieval System CD001, NA, 1110525
Endo pouch 10mm bag tore open inside the patient when attempting to remove the gall bladder. The pouch was inspected for any missing pieces. There were no pieces of the pouch seen inside the patient.
Applied Medical, Inzii Retrieval System CD001, NA,1110525
Endopouch broke during use.
Applied Medical, Inzii Retrieval System CD001, CD001, 1120081 During an appendectomy, the retrieval system failed to open to retrieve the specimen. A second device was used with similar trouble but did open enough to retrieve specimen with difficulty
Covidien Endocatch Gold 173050G, NA, JOHOO28
When physician was performing a laparoscopic cholecystectomy and attempting to put the gallbladder into the Endo Pouch, the bag separated from the ring prior to getting the entire gallbladder in the bag. A second EndoPouch was opened and the same thing happened again. Both pouches had the same lot number.
Applied Medical, Inzii Retrieval System CD001, NA, 1114872
Patient was in for scheduled Laparoscopic Cholecystectomy. Surgeon used Applied Medical Inzii Retrieval System 10mm Endoscopic Pouch. The pouch tore when the surgeon was pulling the gallbladder out thru the trocar. A small piece of the pouch was retrieved from within the patient. Surgeon believes he got all pieces of the pouch out. He believes there is no harm to patient.
Applied Medical, Inzii Retrieval System CD001, NA, 1132177
Endo catch bag detached from metal ring upon deployment of device prior to specimen retrieval. The gallbladder was extracted from the umbilical port site without the use of a bag without further incident.



Additional Information:

1. Class 2 Recall – Anchor Tissue Retrieval System TRS175SB. Medical & Radiation Emitting Device Recalls. March 7, 2011.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=96203

2. Class 2 Recall – Anchor Tissue Retrieval System TRS175SB. Medical & Radiation Emitting Device Recalls. March 7, 2011.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=96203


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