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ANCHOR TISSUE RETRIEVAL SYSTEM TRS175SB2Recalls & reported problems

Conmed Corporation · ANCHOR TISSUE RETRIEVAL SYSTEM, BAG SIZE 1200 ML, PORT SIZE 15 MM · Class 2

Adverse event reports
19
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 20653405986116), received between Nov 20, 2018 and Dec 18, 2025 — classified as 3 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (7 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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 1 reportsMay 2024: 1 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 1 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 1 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 1 reportsMay 2025: 1 reportsJun 2025: 0 reportsJul 2025: 1 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 2 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Detachment of Device or Device Component7
  • Material Fragmentation5
  • Break2
  • Material Puncture/Hole2
  • Fracture1
  • Human-Device Interface Problem1
  • Material Protrusion/Extrusion1

Patient problems

  • No Clinical Signs, Symptoms or Conditions10
  • No Consequences Or Impact To Patient6
  • Blood Loss1
  • Foreign Body In Patient1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

  • MalfunctionDec 18, 2025Material Fragmentation; Material Fragmentation

    THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE DEVICE, TRS175SB2, ANCHOR TISSUE RETRIEVAL SYSTEM, WAS USED DURING AN UNKNOWN PROCEDURE ON (B)(6) 2025 WHEN IT WAS REPORTED, ¿METAL CLAMP DETACHED AFTER PULL BACK (DID NOT TOUCH THE PURPLE BUTTON).¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. FURTHER ASSESSMENT HAS BEEN REQUESTED; HOWEVER, TO DATE WE HAVE NOT RECEIVED A RESPONSE FROM THE REPORTER. 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 23837065 ↗
  • MalfunctionDec 1, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

    A DISTRIBUTOR REPORTED ON BEHALF OF A CUSTOMER THAT THE TRS175SB2, ANCHOR TISSUE RETRIEVAL SYSTEM DEVICE WAS USED IN A VATS LOBECTOMY PROCEDURE ON (B)(6) 2025, AND ¿METAL CLAMP DETACHED AFTER PULL BACK (DID NOT TOUCH THE PURPLE BUTTON). THIS IS NOT AN ISOLATED CASE, OCCURRED A FEW TIMES.¿ THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF AN ALTERNATE DEVICE AND NO DELAY. FURTHER ASSESSMENT FOUND "NO FRAGMENT OR COMPONENT FELL INTO THE SURGICAL SITE." 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 23679067 ↗
  • MalfunctionJul 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

    THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, TRS175SB2, ANCHOR TISSUE RETRIEVAL SYSTEM WAS BEING USED ON (B)(6) 2025 DURING A VATS WEDGE RESECTION AND "WHEN THE BAG WAS RETRACTED TO PUT THROUGH THE TROCAR INTO THE PATIENT THE BAG RIPPED AND SHAFT WAS BENT. THIS HAPPENED WITH TWO BAGS IN A ROW." PER FURTHER ASSESSMENT IT WAS FOUND THAT THE SPECIMEN WAS NOT IN THE BAG WHEN IT RIPPED AND THERE WAS NO FRAGMENTATION OF THE BAG "THE BAG JUST FELL OF THE RIM". THERE WAS NO IMPACT OR INJURY TO THE PATIENT OR USER. THE PROCEDURE WAS COMPLETED WITH A BRIEF DELAY. NO MEDICAL SURGICAL INTERVENTION WAS REQUIRED. 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 22628769 ↗
  • InjuryMay 29, 2025Material Fragmentation; Material Fragmentation

    THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, TRS175SB2, ANCHOR TISSUE RETRIEVAL SYSTEM, WAS BEING USED DURING A LAPAROSCOPIC PROCEDURE ON (B)(6) 2025 WHEN IT WAS REPORTED, ¿SMALL METAL PIECE FELL INTO PATIENT, ONCE BAG DEPLOYED - DIFFICULTY INSERTING TROCAR INTO MIS PORT AND IN MANIPULATING WHITE HANDLE.¿ THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT OR USER. THE PROCEDURE WAS COMPLETED AS PLANNED, USING AN UNKNOWN ALTERNATE DEVICE. FURTHER ASSESSMENT WAS REQUESTED TO DETERMINE IF THE PIECE WAS REMOVED FROM THE PATIENT; HOWEVER, TO DATE NO RESPONSE HAS BEEN RECEIVED FROM THE REPORTER. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF POSSIBLE RETAINED FOREIGN BODY IN PATIENT.

    Patient problems: Foreign Body In Patient

    MAUDE report 22103835 ↗
  • MalfunctionApr 9, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

    CONMED JAPAN REPORTED ON BEHALF OF A CUSTOMER THAT THE TRS175SB2, ANCHOR TISSUE RETRIEVAL SYSTEM DEVICE WAS BEING TESTED PRE-OPERATIVELY ON (B)(6) 2025, AND ¿BAG WAS NOT USABLE BECAUSE THE HARDWARE AND BAG WERE DISCONNECTED WHEN I TRIED TO TAKE THE BAG OUT.¿. THE PROCEDURE WAS COMPLETED WITH THE USE OF AN ALTERNATE SAME DEVICE. THERE WAS NO 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 21805337 ↗
  • MalfunctionDec 12, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

    THE CUSTOMER REPORTED THAT THE DEVICE, TRS175SB2, ANCHOR TISSUE RETRIEVAL SYSTEM, WAS BEING PRE-OPERATIVELY TESTED FOR AN UNKNOWN PROCEDURE ON (B)(6) 2024 WHEN IT WAS REPORTED, ¿¿ THE ANCHOR II BAG COULD NOT BE STORED PROPERLY IN THE SHAFT BEFORE BEING INSERTED INTO THE TROCAR, AND THE BAG CAME OFF.¿ THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER TRS175SB2 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 20912007 ↗
  • MalfunctionSep 5, 2024Material Fragmentation; Material Fragmentation

    THE CUSTOMER REPORTED THAT THE TRS175SB2 ANCHOR TISSUE RETRIEVAL SYSTEM, DEVICE WAS BEING USED ON (B)(6) 2024 DURING AN UNKNOWN PROCEDURE WHEN IT WAS REPORTED ¿BAG BROKE WHILE BEING USED IN PATIENT. BAG JUST RIPPED IN HALF. IT WAS THROWN OUT BUT WRAPPER SAVED.¿. FURTHER ASSESSMENT QUESTIONING FOUND THAT THE DEVICE DID FRAGMENT OR FALL INTO THE SURGICAL SITE. THE FRAGMENTS WERE REMOVED WITH THE USE OF LAPAROSCOPIC INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH THE USE OF AN UNKNOWN ALTERNATE DEVICE AND THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS ¿DISCHARGED FROM THE HOSPITAL.¿. 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 20144066 ↗
  • MalfunctionMay 20, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

    CONMED JAPAN REPORTED ON BEHALF OF A CUSTOMER THAT THE TRS175SB2, ANCR TISSUE RETRIEVAL SYSTEM, 15MM, 1200ML (3/BX) DEVICE WAS BEING USED DURING A VIDEO-ASSISTED THORACOSCOPIC SURGERY PROCEDURE ON (B)(6) 2024, AND ¿THE TISSUE BAG WAS DETACHED FROM THE SUPPORT WIRE AND IT COULD NOT BE OPENED WELL.¿. FURTHER ASSESSMENT FOUND THE DEVICE DID NOT FRAGMENT, "THE TISSUE BAG JUST CAME LOOSE FROM THE SUPPORT WIRE.; WHEN THE NURSE RECEIVED THE ANCHOR II IN THE CLEAN AREA AND PUT THE BAG AWAY, SHE NOTICED AN UNUSUAL RESISTANCE. THE DOCTOR TRIED TO OPEN THE BAG BY INSERTING IT INTO THE PATIENT'S BODY, BUT THE WIRE TISSUE BAG WAS NOT SECURED AND CAME OFF, SO THEY USED A NEW PRODUCT AND WERE ABLE TO HANDLE IT WITHOUT ANY PROBLEMS.". THE CUSTOMER FURTHER INDICATED THAT THE "TISSUE BAG CAME OFF/DETACHED BUT NOTHING FELL INTO THE PATIENT'S BODY" AND ALL DEVICE COMPONENTS WERE RETRIEVED. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE SAME DEVICE AND NO DELAY. 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 19354513 ↗
  • MalfunctionApr 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

    A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE TRS175SB2, ANCR TISSUE RETRIEVAL SYSTEM, 15MM, 1200ML (3/BX) DEVICE WAS BEING USED ON (B)(6) 2024, AND ¿DOCTOR WAS PREFORMING A HYSTERECTOMY W/ FIBROIDS. FIBROIDS WERE LARGE AND NEEDED MORCELLATION PRIOR TO REMOVAL. SURGEON REPLACED AIRSEAL 8MM PORT WITH A 15MM PORT TO PLACE TRS175SB2 THROUGH THE PORT. WHEN PULLING ON BAG, IT SNAPPED COMPLETELY INTO 2.¿ FOLLOW-UP ASSESSMENT FOUND THAT "THE BOTTOM PORTION OF THE BAG DID FALL INTO THE PATIENT. THE PIECE THAT FELL INTO THE PATIENT WAS RETRIEVED. A ROBOTIC ARM HELPED PLACE THE FRAGMENTED PIECE INTO A NEW BAG. THE PATIENT AND USER WERE NOT INJURED." THE PROCEDURE WAS COMPLETED USING A SAME ALTERNATE DEVICE AND WITH A REPORTED DELAY OF 15 MINUTES. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE. AN AIRSEAL, 8 MM PORT AND AN AIRSEAL, 15 MM PORT WILL BE LISTED AS A CONCOMITANT DEVICES. THERE ARE NO ALLEGATIONS FILED AGAINST THEM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19072628 ↗
  • InjuryApr 14, 2023Material Fragmentation; Material Fragmentation

    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 B

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16744806 ↗
  • MalfunctionAug 30, 2021Material Fragmentation; Material Fragmentation

    THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, (B)(4), WAS BEING USED ON (B)(6) 2021 DURING AN UNKNOWN PROCEDURE AND THE ¿RING HOLDING POUCH BROKE LEAVING A PIECE IN THE ABDOMEN THAT HAD TO BE REMOVED WITH A GRASPER.¿ THE PROCEDURE WAS COMPLETED WITH A 10 MINUTE DELAY. THERE NO WAS INJURY OR IMPACT TO THE PATIENT. FURTHER ASSESSMENT WAS SENT; HOWEVER, NO MORE INFORMATION WAS AVAILABLE. 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 12386257 ↗
  • MalfunctionMar 16, 2020Fracture; Fracture

    THE CUSTOMER REPORTED THAT THE DEVICE, TRS175SB2, WAS BEING USED DURING A ROBOTIC LOBECTOMY ON (B)(6) 2020 WHEN THE BAG POPPED DURING THE CASE. THE DOCTORS CONCERN WAS THAT WHEN THE BAG POPS CANCEL CELLS CAN BE SPREAD. THE PROCEDURE WAS COMPLETED WITHOUT ANY REPORT OF DELAY. THERE WAS NO REPORT OF INJURY TO PATIENT OR USER. FURTHER ASSESSMENT INFORMATION WAS REQUESTED; HOWEVER, THE REPORTER DECLINED TO ANSWER THE ASSESSMENT QUESTIONS. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9836852 ↗
  • MalfunctionFeb 28, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

    THE CUSTOMER REPORTED THAT THE TRS175SB2, ANCHOR TISSUE RETRIEVAL SYSTEM WAS USED IN A PROCEDURE ON (B)(6) 2020. WHEN THEY WERE PULLING THE BAG OUT, THEY SAW METAL AND THE PURPLE SLEEVE. THERE WAS A LOOSE PIECE OF METAL THAT CAME OUT OF THE TUBE. THE CUSTOMER WOULD LIKE THE DEVICE TO BE EVALUATED TO BE SURE NOTHING WAS LEFT IN THE PATIENT. THERE IS NO REPORTED KNOWN PATIENT INJURY OR IMPACT. THERE IS NO REPORTED DELAY OF PROCEDURE. THIS REPORT IS BEING RAISED BASED ON DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9769548 ↗
  • MalfunctionDec 11, 2019Break; Break

    THIS DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE TRS175SB2 DEVICE WAS BEING USED DURING A SLEEVE PROCEDURE ON (B)(6) 2019 AND "AT THE TIME OF DEPLOYMENT THE BAG SEPARATED PARTIALLY FROM THE DEVICE BUT REMAINED ATTACHED". THEREFORE, THERE WAS NOTHING TO RETRIEVE FROM THE PATIENT. THERE WAS NO REPORT OF INJURY TO THE USER OR THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9450142 ↗
  • InjuryAug 6, 2019Material Protrusion/Extrusion; Material Protrusion/Extrusion

    THE CONMED REPRESENTATIVE REPORTED ON BEHALF OF THE FACILITY THAT THE TRS175SB2, " WAS DEPLOYED AND THE METAL DISTAL TIP OF THE BAG WAS EXPOSED ON BOTH SIDES. THE STAFF REPORTED THAT THE METAL TIP CAUSED THE PATIENT TO BLEED FROM THE INCISION SITE MORE THAN USUAL." THE PROCEDURE PERFORMED ON (B)(6) 2019 WAS COMPLETED USING ANOTHER OF THE SAME SPECIMEN BAG. CAUTERY WAS USED TO STOP THE BLEEDING. A LARGER INCISION TO REMOVE THE DEVICE WAS NOT NEEDED. THIS REPORT IS BEING RAISED DUE TO PATIENT INJURY.

    Patient problems: Blood Loss

    MAUDE report 8864026 ↗
  • MalfunctionJan 9, 2019Human-Device Interface Problem; Human-Device Interface Problem

    THE CUSTOMER REPORTED THAT (2) TRS175SB2, SPECIMEN BAGS RIPPED DURING THE EXTRACTION PHASE OF A GYN CASE ON (B)(6) 2018. THE BAG RIPPED WHILE REMOVING THE TUBE AND OVARY THROUGH THE ABDOMINAL INCISION. THE SURGICAL TEAM IS FAMILIAR WITH THE DEVICE. ADDITIONAL INFORMATION WAS REQUESTED, HOWEVER THERE WAS NO NEW INFORMATION TO ADD. THERE WAS NO PATIENT INJURY AND NO DELAY REPORTED. THIS REPORT IS BEING RAISED BASED ON DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8231374 ↗
  • MalfunctionNov 30, 2018Break; Break

    THE CUSTOMER REPORTED THAT THE TRS175SB2, ANCHOR SPECIMEN BAG, DURING A ROBOTIC LOBE RESECTION ON (B)(6) 2018, THE FIRST ASSISTANT PLACED THE SPECIMEN BAG INSIDE THE TROCAR INCISION AND AFTER PULLING ON THE BAG'S DRAWSTRING TO GET THE SPECIMEN OUT OF THE CHEST CAVITY VIA THE INCISION, THE BAG BROKE IN THE CENTER OF THE BAG. THE BAG WAS ONLY DEPLOYED ONCE, AND THE STAFF WAS FAMILIAR WITH USING THE DEVICE. THERE WAS NO REPORTED PATIENT INJURY OR IMPACT. THERE WAS NO REPORTED DELAY AND THE PROCEDURE WAS COMPLETED AS PLANNED. THIS REPORT IS BEING RAISED BASED ON DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8119638 ↗
  • MalfunctionNov 20, 2018Material Puncture/Hole; Material Puncture/Hole

    THE CUSTOMER REPORTED THAT THE METAL PRONG HAD RIPPED THROUGH THE BAG, WHILE TRYING TO REMOVE THE SPECIMEN DURING A THORACIC PROCEDURE ON (B)(6) 2018. THEY HAD TO USE 2 BAGS, EACH BAG WAS ONLY DEPLOYED ONCE, THERE WAS SOME RESISTANCE WHILE RELEASING THE BAG. THE BAG WAS NOT PRE-TESTED, AND THE SURGICAL TEAM WAS FAMILIAR WITH THE PRODUCT. THERE WAS NO PATIENT INJURY REPORTED AND THERE WAS A DELAY IN SURGERY, HOWEVER NO TIME LENGTH WAS GIVEN. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH A 3RD BAG OF THE SAME TYPE. THIS REPORT IS BEING RAISED BASED ON DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8088922 ↗
  • MalfunctionNov 20, 2018Material Puncture/Hole; Material Puncture/Hole

    THE CUSTOMER REPORTED THAT THE METAL PRONG HAD RIPPED THROUGH THE BAG, WHILE TRYING TO REMOVE THE SPECIMEN DURING A THORACIC PROCEDURE ON (B)(6) 2018. THEY HAD TO USE 2 BAGS, EACH BAG WAS ONLY DEPLOYED ONCE, THERE WAS SOME RESISTANCE WHILE RELEASING THE BAG. THE BAG WAS NOT PRE-TESTED, AND THE SURGICAL TEAM WAS FAMILIAR WITH THE PRODUCT. THERE WAS NO PATIENT INJURY REPORTED AND THERE WAS A DELAY IN SURGERY, HOWEVER NO TIME LENGTH WAS GIVEN. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH A 3RD BAG OF THE SAME TYPE. THIS REPORT IS BEING RAISED BASED ON DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8088921 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.