ANCHOR TISSUE RETRIEVAL SYSTEM TRS100SB2Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 20653405986109), received between Jul 18, 2018 and Aug 14, 2026 — classified as 11 injuries, 30 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (12 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50256150 ↗
• MalfunctionJun 4, 2026Difficult to Fold, Unfold or Collapse

  A CUSTOMER REPORTED THAT THE TRS100SB2, ANCHOR TISSUE RETRIEVAL SYSTEM DEVICE WAS USED DURING A LAPAROSCOPIC SALPINGECTOMY PROCEDURE ON (B)(6) 2026, AND ¿UPON ATTEMPT TO RETRACT SPECIMEN, THE HANDLE FAILED RETRACTING AND THE METAL APPLIERS PIERCED THROUGH THE BAG. STRENUOUS FORCE WAS REQUIRED TO RETRIEVE DEVICE THROUGH PORT SITE.¿. FURTHER ASSESSMENT CONFIRMED THERE WAS NO INJURY TO PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25390834 ↗
• MalfunctionMar 23, 2026Material Split, Cut or Torn

  A DISTRIBUTOR REPORTED ON BEHALF OF A CUSTOMER THAT THE TRS100SB2, ANCHOR TISSUE RETRIEVAL SYSTEM DEVICE WAS USED IN A LAP CHOLE PROCEDURE ON (B)(6) 2026, AND ¿DURING THE RETRIEVAL OF GALL BLADDER FROM THE PATIENT, THE BOTTOM SIDE OF THE BAG BROKE. GALL BLADDER SLIPPED OUT FROM THE BAG.¿. FURTHER ASSESSMENT FOUND THE BAG WAS "TORN APART AT THE BOTTOM" BUT DID NOT FRAGMENT. THE GALLBLADDER FELL INTO THE PATIENT AND WAS RETRIEVED WITH A GRASPER, AND THE WOUND WAS NOT CONTAMINATED. THE SURGERY WAS COMPLETED AS NORMAL, WITH A DELAY OF 10 MINUTES, AND WITHOUT THE USE OF AN ALTERNATE DEVICE. THERE WAS NO REPORT OF INJURY, MEDICAL/SURGICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24662297 ↗
• InjuryMar 20, 2026Break

  THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE TRS100SB2 ANCHOR TISSUE RETRIEVAL SYSTEM, DEVICE WAS BEING USED ON (B)(6) 2026 DURING A LAP CHOLE PROCEDURE WHEN IT WAS REPORTED WAS REPORTED ¿DURING THE RETRIEVAL OF GALL BLADDER FROM THE PATIENT, THE BOTTOM SIDE OF THE BAG BROKE. GALL BLADDER SLIPPED OUT FROM THE BAG AND RUPTURED. SURGEON HAS TO ¿MANUALLY¿ RETRIEVAL THE GALL STONE FROM PATIENT BODY¿. FURTHER ASSESSMENT QUESTIONING FOUND THAT THE GALLBLADDER DID RUPTURE CAUSING CONTAMINATION, HOWEVER, NO MEDICAL/SURGICAL INTERVENTION WAS REQUIRED FOR THE PATIENT. THE PROCEDURE WAS COMPLETED AND THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE REPORTED INJURY DUE PATIENT GALLBLADDER RUPTURING CAUSING CONTAMINATION.

  Patient problems: Rupture

  MAUDE report 24647536 ↗
• MalfunctionMay 19, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, TRS100SB2, ANCHOR TISSUE RETRIEVAL SYSTEM, WAS BEING USED DURING A LAPAROSCOPIC APPENDECTOMY PROCEDURE ON (B)(6) 2024 WHEN IT WAS REPORTED, ¿ANCHOR TISSUE RETRIEVAL BAG DID NOT INITIALLY DEPLOY WHEN THE BUTTON WAS PRESSED. THEN, WHEN IT DID DEPLOY, THE METAL TORE THROUGH THE RETRIEVAL BAG AND NEARLY INJURED THE PATIENT. FAILURE OF INSTRUMENT OCCURRED WHILE THE DEVICE WAS INSIDE THE PATIENT.¿ THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. THE PROCEDURE WAS COMPLETED AS PLANNED. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22042848 ↗
• MalfunctionMay 12, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE TRS100SB2, ANCHOR TISSUE RETRIEVAL SYSTEM WAS BEING USED ON 12MAR25 DURING A LAP CHOLE AND ¿THE METAL DEPLOYMENT FAILED TO RELEASE PROPERLY, AND THE METAL PRONGS CAME THROUGH THE BAG INSIDE THE PATIENT AND THE ENTIRE DEVICE/BAG/SPECIMEN HAD TO BE REMOVED FROM THE PATIENT TOGETHER IN ORDER TO RELEASE IT. WE NEEDED TO GO BACK IN LAPAROSCOPICALLY AFTER THIS DEPLOYED WRONG.¿ PER FURTHER ASSESSMENT IT WAS REPORTED "...THEY WERE NOT ABLE TO FINISH THE PROCEDURE AS PLANNED AND NEEDED TO RETURN THE CAMERA AND TOOLS BACK INTO THE PATIENT LAPAROSCOPICALLY TO FIX THE BAG ISSUE, ENSURE THERE WAS NO ADVERSE IMPACT TO THE PATIENT, AND TO SAFELY REMOVE THE BAG, DEPLOYMENT MECHANISM, AND SPECIMEN FROM THE PATIENT BEFORE FINISHING. AS SUCH I DON'T BELIEVE A NEW SURGICAL INTERVENTION WAS REQUIRED BUT RATHER AN EXTENSION OF THE LAPAROSCOPIC PROCEDURE..." THERE WAS NO IMPACT OR INJURY TO THE PATIENT OR USER AND THE PATIENT WAS REPORTED AS ¿NO APPARENT HARM¿. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22001562 ↗
• MalfunctionApr 24, 2025Material Twisted/Bent; Material Twisted/Bent

  THE DISTRIBUTOR REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, TRS100SB2, ANCHOR TISSUE RETRIEVAL SYSTEM WAS BEING USED AND "THE BAG IS UNABLE TO RETRACT PROPERLY. THE METAL STICKS OUT OF THE RING WHEN THE ROD IS PULLED BACK TO CLOSE THE SPECIMEN BAG.¿ THERE WAS NO IMPACT OR INJURY TO THE PATIENT OR USER. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21898366 ↗
• MalfunctionApr 24, 2025Material Twisted/Bent; Material Twisted/Bent

  THE DISTRIBUTOR REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, TRS100SB2, ANCHOR TISSUE RETRIEVAL SYSTEM WAS BEING USED AND "THE BAG IS UNABLE TO RETRACT PROPERLY. THE METAL STICKS OUT OF THE RING WHEN THE ROD IS PULLED BACK TO CLOSE THE SPECIMEN BAG.¿ THERE WAS NO IMPACT OR INJURY TO THE PATIENT OR USER. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21898319 ↗
• MalfunctionApr 24, 2025Material Twisted/Bent; Material Twisted/Bent

  THE DISTRIBUTOR REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, TRS100SB2, ANCHOR TISSUE RETRIEVAL SYSTEM WAS BEING USED AND "THE BAG IS UNABLE TO RETRACT PROPERLY. THE METAL STICKS OUT OF THE RING WHEN THE ROD IS PULLED BACK TO CLOSE THE SPECIMEN BAG.¿ THERE WAS NO IMPACT OR INJURY TO THE PATIENT OR USER. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21898315 ↗
• MalfunctionMar 7, 2025Difficult to Open or Close; Difficult to Open or Close

  THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE DEVICE, TRS100SB2, ANCHOR TISSUE RETRIEVAL SYSTEM, WAS BEING USED DURING A LAP CHOLE PROCEDURE ON (B)(6) 2025 WHEN IT WAS REPORTED, ¿THE METAL ROD PROTRUDES OUT OF THE BAG WHEN THE STRING IS PULLED TO CLOSE THE RETRIEVAL BAG AFTER SPECIMEN IS PUT IN. THE STRING COULD NOT TIGHTEN FULLY (THUS BAG UNABLE TO CLOSE FULLY) AS THE ROD IS STILL STUCK INSIDE THE RING.¿. THERE WAS NO REPORT OF MEDICAL INTERVENTION OR HOSPITALIZATION FOR THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A 10-MINUTE DELAY. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21545641 ↗
• MalfunctionJan 7, 2025Material Perforation; Material Perforation

  THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE DEVICE, TRS100SB2, ANCHOR TISSUE RETRIEVAL SYSTEM, WAS BEING USED DURING A LAP CHOLE PROCEDURE ON (B)(6) 2024 WHEN IT WAS REPORTED, ¿THE METAL PORTION OF THE ANCHOR BAG WAS UNABLE TO CLOSE AS THE METAL PORTION WAS PROTRUDING OUT OF THE ANCHOR BAG. HENCE, HAD TO USE ANOTHER BAG.¿. FURTHER ASSESSMENT INFORMATION FOUND THAT THE DEVICE MALFUNCTION WAS DISCOVERED PRIOR TO USE OF THE DEVICE ON THE PATIENT. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21091492 ↗
• InjuryDec 30, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  A CUSTOMER REPORTED THAT THE DEVICE, TRS100SB2, ANCHOR TISSUE RETRIEVAL SYSTEM, WAS USED IN A CHOLECYSTECTOMY PROCEDURE ON (B)(6) 2024, AND ¿WHILE TRYING TO REMOVE THE SPECIMEN FROM THE UMBILICUS SITE WITH A KELLY, THE BAG BROKE AT THE BOTTOM SPILLING THE GALLBLADDER AND CONTENTS". FURTHER ASSESSMENT FOUND THAT "THE SEAM BROKE AND THE BAG RIPPED OPEN. THEY OPENED A NEW BAG" AND THERE WAS A DELAY OF "30 MINS. THEY DID COMPLETE AS NORMAL; HOWEVER THEY WOULD HAVE HAD TO IRRIGATE THE ABDOMEN TO CLEAN IT OUT.". AS A RESULT OF THE EVENT, THE WOUND CLASSIFICATION WAS CHANGED TO "CLASS 3". IT WAS REPORTED THAT THE PATIENT WAS NOT INJURED. THE PROCEDURE WAS COMPLETED, AND THERE WAS NO REPORT OF MEDICAL/SURGICAL INTERVENTION OR EXTENDED HOSPITALIZATION REQUIRED FOR THE PATIENT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF CHANGE IN WOUND CLASSIFICATION TO "CLASS 3".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21039037 ↗
• InjuryNov 22, 2024Break; Break

  THIS COMPLAINT WAS CREATED BY THE FINDING OF MAUDE REPORT NUMBER 20368549 ON 7NOV2024. THE CURRENT COMPLAINT DATABASE HAS BEEN RESEARCHED FOR THIS EVENT AND THERE WERE NO FINDINGS. THE REPORT WAS FOUND TO BE WRITTEN AGAINST A TRS100SB2, ANCHOR TISSUE RETRIEVAL SYSTEM, DEVICE. THE DATE OF THE PROCEDURE WAS ON (B)(6) 2024. THE REPORTER REMAINED ANONYMOUS. THE REPORT STATES, ¿DURING A LAPAROSCOPIC PROCEDURE, A 10MM TISSUE RETRIEVAL BAG BROKE WHEN TRYING TO EXTRACT THE SPECIMEN OUT OF A LAPAROSCOPIC PORT SITE. THIS RESULTED IN A LARGER INCISION BEING MADE TO EXTRACT THE BAG AND AN ADDITIONAL HOUR UNDER ANESTHESIA.¿ THERE WAS NO REPORT OF EXTENDED HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF LARGER INCISION REQUIRED TO REMOVE BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20756772 ↗
• InjuryNov 7, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  A CUSTOMER REPORTED THAT THE (B)(6), ANCHOR TISSUE RETRIEVAL SYSTEM DEVICE WAS USED IN AN UNKNOWN PROCEDURE ON (B)(6) 2024, AND ¿RETRIEVAL BAG RUPTURED AS IT WAS BEING PULLED OUT OF ABDOMEN, AND THE CONTENTS SPILLED ALL OVER THE ABDOMEN. THIS ADDED AN EXTRA 25 MINUTES TO THE CASE TO CLEAN UP GALLBLADDER AND CONTENTS¿. THE PROCEDURE WAS COMPLETED WITH "NO CLINICAL SIGNIFICANCE" AND "NO INJURY TO PATIENT OR STAFF". FURTHER ASSESSMENT FOUND THAT "THE SURGEON HAD TO DO A WASHOUT" OF THE PATIENT'S ABDOMEN, AND THE WOUND CLASSIFICATION WAS CHANGED DUE TO CONTAMINATION OF THE SITE; HOWEVER, THE CUSTOMER CONFIRMED THAT THE PATIENT WAS NOT INJURED. THERE WAS NO KNOWN FRAGMENTATION OF THE DEVICE. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF THE WOUND CLASSIFICATION BEING CHANGED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20628874 ↗
• MalfunctionOct 29, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  A CUSTOMER REPORTED THAT THE TRS100SB2, ANCHOR TISSUE RETRIEVAL SYSTEM DEVICE WAS BEING USED IN A LAP APPY PROCEDURE ON (B)(6) 2024, AND "THE BAG BREAKS". THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF AN ALTERNATE DEVICE AND WITH A DELAY OF 5 MINUTES. FURTHER ASSESSMENT FOUND THAT THE "BAG DETACHED FROM DEVICE IMPROPERLY" WHILE INSIDE THE SURGICAL SITE. THE BAG DID NOT FRAGMENT; THE SPECIMEN DID NOT FALL OUT OF THE BAG, AND WAS ¿PULLED OUT¿. THERE WAS NO INJURY, MEDICAL/SURGICAL INTERVENTION OR EXTENDED HOSPITALIZATION REQUIRED FOR THE PATIENT, AND THE PATIENT'S CURRENT STATUS IS "FINE". THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20556322 ↗
• MalfunctionOct 24, 2024Material Rupture; Material Rupture

  THE CUSTOMER REPORTED THAT THE TRS100SB2, ANCHOR TISSUE RETRIEVAL SYSTEM, DEVICE WAS BEING USED ON (B)(6) 2024 DURING A LAPAROSCOPIC ROUX EN Y GASTRIC BYPASS PROCEDURE WHEN IT WAS REPORTED ¿WHEN EXTRACTING THE FIRED 25MM EEA INTRALUMINAL STAPLER, THE ENDOCATCH (ANCHOR TISSUE RETRIEVAL SYSTEM BY CONMED) MALFUNCTIONED. THE SPECIMEN BAG THAT WAS SUPPOSED TO PROTECT THE15MM PORT SITE (ABDOMINAL WALL TISSUE) FROM SMALL BOWEL CONTENTS (SCANT AMOUNT) DID NOT SEAL PROPERLY AND HAD COME UNDONE DURING THE EXTRACTION. AS A RESULT, THE PATIENT TISSUE (ABDOMINAL WALL TISSUE) WAS EXPOSED. A MIXTURE OF IODINE AND SALINE WAS IRRIGATED TO THE SITE AS INFECTION PREVENTION.¿. FURTHER ASSESSMENT QUESTIONING FOUND THAT THE DEVICE DID NOT FRAGMENT OR FALL INTO THE SURGICAL SITE. "NO APPARENT HARM - REACHED PATIENT/PERSON, INCONVENIENT." THE PROCEDURE WAS COMPLETED WITH THE USE OF AN ALTERNATE DEVICE. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20522487 ↗
• MalfunctionOct 22, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  A CUSTOMER REPORTED THAT THE TRS100SB2, ANCHOR TISSUE RETRIEVAL SYSTEM DEVICE WAS BEING USED IN AN UNKNOWN PROCEDURE ON (B)(6)2024, AND ¿LAPAROSCOPIC CHOLECYSTECTOMY PERFORMED, DURING REMOVAL OF THE BAG WITH THE SPECIMEN, THE BAG TORE OPEN. MALFUNCTIONED DEVICE WAS SAFELY REMOVED SAFELY FROM PATIENTS' ABDOMEN AND A NEW TISSUE RETRIEVAL BAG WAS OPEN AND USED.¿. THE PROCEDURE WAS COMPLETED WITH AN ALTERNAT DEVICE AND NO REPORTED DELAY. FURTHER ASSESSMENT QUESTIONS WERE SENT, AND A GOOD FAITH EFFORT WAS MADE TO OBTAIN FURTHER INFORMATION; HOWEVER, NO RESPONSE HAS BEEN RECEIVED. THERE WAS NO REPORT OF FRAGMENTATION OF THE DEVICE NOR OF INJURY, MEDICAL/SURGICAL INTERVENTION OR EXTENDED HOSPITALIZATION REQUIRED FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20504568 ↗
• MalfunctionOct 3, 2024Break; Break

  CONMED CANADA REPORTED ON BEHALF OF THE CUSTOMER THAT THE TRS100SB2, ANCHOR TISSUE RETRIEVAL SYSTEM, DEVICE WAS BEING USED ON (B)(6) 2024 DURING A LAP CHOLE PROCEDURE WHEN IT WAS REPORTED ¿BAG WAS DIFFICULT TO DEPLOY AND RETRIEVAL BAG SEAM AT BOTTOM OF BAG SPLIT OPEN.¿. IT WAS ALSO REPORTED THAT THERE WAS "NO CLINICAL SIGNIFICANCE. NO INJURY TO PATIENT OR STAFF.". FURTHER ASSESSMENT WAS ATTEMPTED BUT TO DATE, NO FURTHER INFORMATION IS AVAILABLE. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20359823 ↗
• MalfunctionOct 3, 2024Material Perforation; Material Perforation

  THE CUSTOMER REPORTED THAT THE TRS100SB2, ANCHOR TISSUE RETRIEVAL SYSTEM WAS BEING USED ON (B)(6) 2024 DURING A LAP CHOLE PROCEDURE WHEN IT WAS REPORTED ¿2 OF THE ANCHOR TISSUE BAGS (TRS100SB2) THAT WERE DEFECTIVE.¿. FURTHER ASSESSMENT QUESTIONING FOUND THAT ¿ONE BAG WOULD NOT CLOSE, THE OTHER BAG TORE WHEN TRYING TO CLOSE IT. IT WAS ALSO CONFIRMED THAT THE BAG DID NOT FRAGMENT OR FALL INTO THE SURGICAL SITE. A 3RD BAG WAS USED TO REMOVE THE SPECIMEN¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION TO THE PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20358478 ↗
• InjurySep 13, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, TRS100SB2, ANCHOR TISSUE RETRIEVAL SYSTEM, WAS BEING USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE ON (B)(6) 2024 WHEN IT WAS REPORTED, "BAG RIPPED THROUGH THE BOTTOM SEAM AS TRYING TO PULL GALLBLADDER OUT - MADE SKIN INCISION BIGGER AND PULLED OUT OF SKIN INCISION". FURTHER ASSESSMENT QUESTIONING FOUND "THE SPECIMEN CAME OUT OF THE BOTTOM SEAM OF THE BAG AND BECAME STUCK IN THE SURGICAL SITE (SKIN INCISION). THE SPECIMEN (GALLBLADDER) WAS RETRIEVED" USING A KELLY CLAMP TO PULL IT OUT OF THE SKIN INCISION. THERE WAS NO REPORT OF EXTENDED HOSPITALIZATION FOR THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A 5-MINUTE DELAY. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF ENLARGEMENT OF INCISION TO RETRIEVE SPECIMEN.

  Patient problems: Insufficient Information

  MAUDE report 20212113 ↗
• InjurySep 12, 2024Unintended Movement; Sharp Edges; Unintended Movement; Sharp Edges

  THIS COMPLAINT WAS CREATED BY THE FINDING OF MAUDE REPORT NUMBER 19852413. THE CURRENT COMPLAINT DATABASE HAS BEEN RESEARCHED FOR THIS EVENT AND THERE WERE NO FINDINGS. THE REPORT WAS FOUND TO BE WRITTEN AGAINST THE TRS100SB2, ANCHOR TISSUE RETRIEVAL SYSTEM FOR THE REPORTED EVENT DATE OF 15JUL2024. THIS WAS REPORTED AS A PRODUCT PROBLEM NOT AN ADVERSE EVENT; HOWEVER, THE REPORT STATES: ¿THE POUCH RETRIEVAL BAG WAS USED TO RETRIEVE THE GALLBLADDER. ONCE BAG WAS DEPLOYED THE METAL CLAPS TORE THROUGH BAG AND LACERATED PT'S LIVER.¿. FURTHER ASSESSMENT IS NOT POSSIBLE AS THE ACCOUNT AND CONTACT INFORMATION FOR THIS REPORT ARE UNKNOWN. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF LIVER LACERATION TO THE PATIENT.

  Patient problems: Liver Laceration(s)

  MAUDE report 20199674 ↗
• MalfunctionJul 30, 2024Activation Problem; Activation Problem

  A CUSTOMER REPORTED THAT THE TRS100SB2, ANCR TISSUE RETRIEVAL SYSTEM, 10MM, 175ML (5/BX) DEVICE WAS BEING USED DURING A LAP CHOLE PROCEDURE ON 03JUL24, AND ¿METAL ARMS DID NOT DEPLOY CORRECTLY PIERCED THROUGH INTO BAG¿, AND THE CUSTOMER NOTED ¿POTENTIAL ADVERSE OUTCOME¿. FOLLOW-UP ASSESSMENT FOUND THAT WHEN THE EVENT OCCURRED, THE DEVICE WAS NOT IN CONTACT WITH THE PATIENT AND THE SPECIMEN WAS NOT IN THE BAG; THE BAG DID NOT FRAGMENT; NO SPECIMEN CONTENT AND NO DEVICE COMPONENT OR FRAGMENT FELL INTO THE SURGICAL SITE. THERE WAS A DELAY OF 15 MINUTES. THERE WAS NO ADVERSE OUTCOME, INJURY, MEDICAL/SURGICAL INTERVENTION OR EXTENDED HOSPITAL STAY REQUIRED FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19860168 ↗
• InjuryApr 23, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  THE CUSTOMER REPORTED THAT THE DEVICE, TRS100SB2, ANCR TISSUE RETRIEVAL SYSTEM, 10MM, 175ML (5/BX), WAS BEING USED IN AN UNKNOWN PROCEDURE ON(B)(6) 2024 WHEN IT WAS REPORTED, ¿BAG RIPPED AT BASE WHEN BEING REMOVED FROM PATIENT; CONTENTS SPILLED BACK INTO ABDOMEN; USED STONE FORCEPS TO GRAB SOME PIECES AND THEN A NEW BAG FOR THE REST OF SPECIMEN.¿. FURTHER ASSESSMENT FOUND THAT ¿THERE WERE NO FRAGMENTS FROM THE RETRIEVAL BAG. THE SEAM RIPPED AND THE CONTENTS SPILLED OUT. THEY ATTEMPTED TO REMOVE ALL THE FECAL MATTER THAT SPILLED OUT. THE MINOR INJURY THAT OCCURRED WAS LONGER ANESTHESIA TIME, AND POSSIBLE FECAL CONTAMINATION OF THE ABDOMEN¿. THERE WAS NO REPORT OF MEDICAL INTERVENTION OR HOSPITALIZATION FOR THE PATIENT. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE BAG. THE DELAY TIME IS NOT KNOWN. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF POSSIBLE CONTAMINATION OF THE ABDOMEN DUE TO SPILLED FECAL MATTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19162421 ↗
• MalfunctionApr 11, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE TRS100SB2, ANCR TISSUE RETRIEVAL SYSTEM, 10MM, 175ML (5/BX) WAS BEING USED ON (B)(6) 2024 AND THE ¿ANCHOR BAG TRS100SB2 WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY AND AS THE SURGEON PULLED ON THE BAG, THE BAG RIPPED A WHOLE RIGHT THROUGH THE BOTTOM OF THE BAG. BAG WAS USED PROPERLY, NO ADVERSE CONDITIONS¿. PER FURTHER ASSESSMENT IT WAS FOUND THAT THE BAG DID NOT FRAGMENT. THE SPECIMEN DID FALL BACK INTO THE SURGICAL SITE BUT WAS RETRIEVED WITH A KELLY AND THE SURGICAL SITE WAS NOT CONTAMINATED. NO ADDITIONAL INCISIONS WERE REQUIRED TO RETRIEVE THE SPECIMEN: "IT WAS PULLED OUT THOUGH AN EXISTING 10MM SKIN INCISION, THE INCISION THAT ORIGINALLY HAD THE 10MM TROCAR AND BAG PLACED DOWN.". THERE WAS NO INJURY TO THE PATIENT OR USER. THERE WAS A 1 MINUTE DELAY AND THE PROCEDURE WAS COMPLETED WITHOUT AN ALTERNATE DEVICE. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19087122 ↗
• MalfunctionMar 5, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE TRS100SB2, ANCR TISSUE RETRIEVAL SYSTEM, 10MM, 175ML (5/BX) DEVICE WAS BEING USED DURING A LAP CHOLE PROCEDURE ON (B)(6) 2024, AND ¿BAG RIPPED DURING RETRIEVAL OF SPECIMEN¿. THE PROCEDURE WAS COMPLETED WITHOUT DELAY AND WITHOUT THE USE OF AN ALTERNATE DEVICE. FOLLOW-UP ASSESSMENT FOUND THAT THE RIP OCCURRED INSIDE THE ABDOMINAL CAVITY AS THE "SPECIMEN WAS BEING PUT INTO BAG". THERE WERE NO FRAGMENTS AND THE SURGEON "WAS STILL ABLE TO REMOVE SPECIMEN WITH RIP." THERE WAS NO REPORTED INJURY, MEDICAL/SURGICAL INTERVENTION OR EXTENDED HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18836503 ↗