2EZee Specimen Retrieval 550-000-200Recalls & reported problems

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 00877972007289), received between Jul 12, 2019 and Oct 23, 2020 — classified as 1 injury, 53 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (40 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 54 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 23, 2020Break; Break

  DOCTOR WAS PERFORMING GALLBLADDER SURGERY, AND THE 550-000-200 BAG BURST AT THE BOTTOM DURING REMOVAL. HE USED TWO ADDITIONAL BAGS DURING SAME SURGERY WITH THE SAME RESULT. THE PROCEDURE WAS FINISHED WITH A FOURTH GENICON BAG. NO HARM TO PATIENT. BAGS WERE DISCARDED. THE SITE WAS NOT ENLARGED AND THE PORT SITE WAS 10 MM. NOTE: THIS MDR IS FOR THE 1ST 500-000-200 SPECIMEN RETRIEVAL BAG LISTED IN THE COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10727196 ↗
• MalfunctionAug 13, 2020Material Rupture; Material Rupture

  DOCTOR HAD THE POLY BAG OUT OF THE TROCAR SITE HALFWAY. HE THEN PROCEEDED TO PUT A CLAMP HORIZONTAL ACROSS THE BAG AND CLAMPED IT ABOUT HALF WAY AND ALL THE WAY ACROSS. HE THEN USED THE CLAMP AS A T-HANDLE AND PULLED ON IT AS LEVERAGE. THE BAG STARTED TO STRETCH AND RIGHT BEFORE THE GALL BLADDER CAME OUT THE BAG BROKE IN HALF. THE GALL BLADDER HOWEVER WAS STUCK WHERE DOCTOR COULD REACH INTO THE TROCAR SITE AND GRAB IT WITH SOME PICKUPS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10400946 ↗
• MalfunctionAug 11, 2020Material Rupture; Material Rupture

  TWO DOCTORS ON THE TRAUMA/SURGERY TEAM USED THREE BAGS IN THREE CASES AND EACH ONE RIPPED WHILE ATTEMPTING TO EXTRACT THE SPECIMEN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10394467 ↗
• MalfunctionAug 11, 2020Material Rupture; Material Rupture

  TWO DOCTORS ON THE TRAUMA/SURGERY TEAM USED THREE BAGS IN THREE CASES AND EACH ONE RIPPED WHILE ATTEMPTING TO EXTRACT THE SPECIMEN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10394466 ↗
• MalfunctionAug 11, 2020Material Rupture; Material Rupture

  TWO DOCTORS ON THE TRAUMA/SURGERY TEAM USED THREE BAGS IN THREE CASES AND EACH ONE RIPPED WHILE ATTEMPTING TO EXTRACT THE SPECIMEN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10394464 ↗
• MalfunctionAug 10, 2020Material Rupture; Material Rupture

  LAP CHOLE CASE WITH THE DOCTOR USING THE NEW 550-000-200 BAG AT THE HOSPITAL. THE CUSTOMER SAID SEVERAL DOCTORS COMPLAINED ABOUT THE QUALITY OF THE ORIGINAL POLY BAG, AND PREVIOUSLY HAD 2 TORN BAGS BUT THEY DID NOT NOTE THE ITEM OR LOT NUMBERS. SO WE CONVERTED TO THE NEW BAGS IN AN ATTEMPT TO SAVE THE ACCOUNT. IN THE FIRST CASE WHILE TRIALING THE NEW GENICON BAG, THE BAG TORE WHILE TRYING TO REMOVE FROM PATIENT. THE TEAR WAS NEAR THE BOTTOM OF THE BAG, AND THE STONE FELL BACK INTO THE ABDOMEN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10387875 ↗
• MalfunctionAug 10, 2020Material Rupture; Material Rupture

  DOCTOR DID ONE OTHER CASE WITH THE BAG AND IT WORKED AS EXPECTED. CRD MENTIONED ANOTHER DOCTOR HAD A TEAR (DESCRIBED IN PER 00576), AND THAT DOCTOR IN THIS EVENT ALSO HAD A SIMILAR TEAR - AT THE SEAM TOWARD THE BOTTOM OR POINT OF THE BAG.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10387809 ↗
• MalfunctionAug 10, 2020Material Rupture; Material Rupture

  THE SPECIMEN RETRIEVAL BAG LEAKED AT THE BOTTOM AS BAG WAS COMING OUT OF THE ABDOMEN. ONE PHYSICIAN HAD THE BAG RUPTURE DURING 2 DIFFERENT CASES WITH CONTENTS IN THE BAG, AS IT WAS BEING BROUGHT THROUGH THE PORTAL INCISIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10387703 ↗
• MalfunctionAug 10, 2020Material Rupture; Material Rupture

  THE SPECIMEN RETRIEVAL BAG LEAKED AT THE BOTTOM AS BAG WAS COMING OUT OF THE ABDOMEN. ONE PHYSICIAN HAD THE BAG RUPTURE DURING 2 DIFFERENT CASES WITH CONTENTS IN THE BAG, AS IT WAS BEING BROUGHT THROUGH THE PORTAL INCISIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10387664 ↗
• MalfunctionAug 10, 2020Material Rupture; Material Rupture

  THE SPECIMEN RETRIEVAL BAG LEAKED AT THE BOTTOM AS BAG WAS COMING OUT OF THE ABDOMEN. ONE PHYSICIAN HAD THE BAG RUPTURE DURING 2 DIFFERENT CASES WITH CONTENTS IN THE BAG, AS IT WAS BEING BROUGHT THROUGH THE PORTAL INCISIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10387656 ↗
• MalfunctionAug 10, 2020Material Rupture; Material Rupture

  GALLBLADDER HAD MULTIPLE STONES. NOTICEABLY LARGE. SURGEON QUESTIONED IF BAG HAD ELASTICITY, SEEMED TO BE "STRETCHING." THEN BURST AT BOTTOM. ASKED FOR SECOND "NEW" 200, AGAIN EXPERIENCED THE ELASTICITY OF BAG AS HE WAS TUGGING, TWISTING. DID LENGTHEN INCISION WITH SCALPEL. AGAIN ASKED IF BAG "STRETCHES." THEN IT BURST AT BOTTOM AGAIN. SURGEON THEN MADE INCISION SIGNIFICANTLY LARGER. UTILIZED ORIGINAL 200. REMOVED WITHOUT INCIDENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10386049 ↗
• MalfunctionAug 10, 2020Material Rupture; Material Rupture

  GALLBLADDER HAD MULTIPLE STONES. NOTICEABLY LARGE. SURGEON QUESTIONED IF BAG HAD ELASTICITY, SEEMED TO BE "STRETCHING." THEN BURST AT BOTTOM. ASKED FOR SECOND "NEW" 200, AGAIN EXPERIENCED THE ELASTICITY OF BAG AS HE WAS TUGGING, TWISTING. DID LENGTHEN INCIISION WITH SCALPEL. AGAIN ASKED IF BAG "STRETCHES." THEN IT BURST AT BOTTOM AGAIN. SURGEON THEN MADE INCISION SIGNIFICANTLY LARGER. UTILIZED ORIGINAL 200. REMOVED WITHOUT INCIDENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10385999 ↗
• MalfunctionAug 10, 2020Material Rupture; Material Rupture

  FROM INITIAL REPORT: (B)(6) 2019- DURING TRIAL OF NEW FORMULARY SPECIMEN RETRIEVAL BAG FROM GENICON, THE BAG TORE AND FAILED 3 OUT OF 5 ATTEMPTS TO USE IT. THE REP WAS PRESENT FOR THE TRIAL AND AVAILABLE FOR QUESTIONS AND INSTRUCTIONS ON USE. REVISION 1, FROM PRODUCT EXPERIENCE REPORT (PER) 00654: DURING TRIAL OF NEW FORMULARY SPECIMEN RETRIEVAL BAG FROM GENICON, THE BAG TORE AND FAILED 3 OUT OF 5 ATTEMPTS TO USE IT. THE BAG POPPED AT THE BOTTOM OF THE BAG DURING ATTEMPTED RETRIEVAL THROUGH THE DEFECT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10385400 ↗
• MalfunctionAug 10, 2020Material Rupture; Material Rupture

  FROM INITIAL REPORT: (B)(6) 2019- DURING TRIAL OF NEW FORMULARY SPECIMEN RETRIEVAL BAG FROM GENICON, THE BAG TORE AND FAILED 3 OUT OF 5 ATTEMPTS TO USE IT. THE REP WAS PRESENT FOR THE TRIAL AND AVAILABLE FOR QUESTIONS AND INSTRUCTIONS ON USE. REVISION 1, FROM PRODUCT EXPERIENCE REPORT (PER) 00654: DURING TRIAL OF NEW FORMULARY SPECIMEN RETRIEVAL BAG FROM GENICON, THE BAG TORE AND FAILED 3 OUT OF 5 ATTEMPTS TO USE IT. THE BAG POPPED AT THE BOTTOM OF THE BAG DURING ATTEMPTED RETRIEVAL THROUGH THE DEFECT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10385377 ↗
• MalfunctionAug 10, 2020Material Rupture; Material Rupture

  FROM INITIAL REPORT: (B)(6) 2019- DURING TRIAL OF NEW FORMULARY SPECIMEN RETRIEVAL BAG FROM GENICON, THE BAG TORE AND FAILED 3 OUT OF 5 ATTEMPTS TO USE IT. THE REP WAS PRESENT FOR THE TRIAL AND AVAILABLE FOR QUESTIONS AND INSTRUCTIONS ON USE. REVISION 1, FROM PRODUCT EXPERIENCE REPORT (PER) 00654: DURING TRIAL OF NEW FORMULARY SPECIMEN RETRIEVAL BAG FROM GENICON, THE BAG TORE AND FAILED 3 OUT OF 5 ATTEMPTS TO USE IT. THE BAG POPPED AT THE BOTTOM OF THE BAG DURING ATTEMPTED RETRIEVAL THROUGH THE DEFECT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10385376 ↗
• MalfunctionAug 10, 2020Material Rupture; Material Rupture

  DOCTOR HAD THE POLY BAG OUT OF THE TROCAR SITE HALFWAY. HE THEN PROCEEDED TO PUT A CLAMP HORIZONTAL ACROSS THE BAG AND CLAMPED IT ABOUT HALF WAY AND ALL THE WAY ACROSS. HE THEN USED THE CLAMP AS A T-HANDLE AND PULLED ON IT AS LEVERAGE. THE BAG STARTED TO STRETCH AND RIGHT BEFORE THE GALL BLADDER CAME OUT THE BAG BROKE IN HALF. THE GALL BLADDER HOWEVER WAS STUCK WHERE DOCTOR COULD REACH INTO THE TROCAR SITE AND GRAP IT WITH SOME PICKUPS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10385373 ↗
• MalfunctionAug 7, 2020Material Rupture; Material Rupture

  DOCTOR DID A CASE ON FRIDAY (B)(6) 2019 AND THE GENICON RETRIEVAL BAG HE USED BROKE WHILE RETRIEVING THE SPECIMEN. REF# (B)(4) LOT# 19855-A EXP. DATE 3/16/20. ADDITIONAL DATA REGARDING THE SAME CASE: ON (B)(6), DOCTOR WAS COMPLETING A ROBOTIC LAP VENTRAL HERNIA REPAIR. HE DEPLOYED A 2EZEE RETRIEVAL BAG TO REMOVE EXCESS FATTY TISSUE. WHILE REMOVING THE BAG FROM THE ABDOMEN THE TIP OF THE BAG TORE, SPILLING THE MAJORITY OF THE CONTENT INTO THE CAVITY. AT THIS POINT, THE BAG WAS EASILY REMOVED AND REMAINING TISSUE WAS REMOVED VIA THE TROCAR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10382944 ↗
• MalfunctionAug 7, 2020Material Rupture; Material Rupture

  FROM INITIAL REPORT: THE SPECIMEN RETRIEVAL BAG BURST WHEN ATTEMPTING TO REMOVE GALL BLADDER. THERE WAS A STONE PRESENT AND THE PORT SITE WAS TOO SMALL AND HAD TO BE INCREASED IN DIAMETER BUT WHEN THEY TRIED TO PULL IT THROUGH, THE BAG BURST WITH THE GALL BLADDER HALF WAY OUT. ADDITIONAL INFORMATION: THE SPECIMEN RETRIEVAL BAG BURST WHEN ATTEMPTING TO REMOVE GALL BLADDER. THERE WAS A STONE PRESENT AND THE PORT SITE WAS TOO SMALL AND HAD TO BE INCREASED IN DIAMETER BUT WHEN THEY TRIED TO PULL IT THROUGH, THE BAG BURST WITH THE GALL BLADDER HALF WAY OUT. (B)(6) 2019) PER REP, BAG BURST ALONG THE SEAM IN BOTTOM CURVE OF THE BAG JUST BEFORE THE DISTAL TIP. THE SPECIMEN WAS HALFWAY OUT OF THE PORT SITE SO SURGEON USED A GRASPER TO COMPLETELY REMOVE IT, AND ALSO USED THE GRASPER TO REMOVE A PIECE OF THE BAG THAT HAD FALLEN INTO THE ABDOMEN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10382942 ↗
• MalfunctionAug 6, 2020Material Rupture; Material Rupture

  DURING A LAP CHOLI PROCEDURE, THE DOCTOR WAS ATTEMPTING TO REMOVE THE GALLBLADDER USING THE 2EZEE BAG. WHILE PULLING ON THE BAG, THE BOTTOM PORTION OF THE BAG BROKE SPILLING THE CONTENTS BACK INTO THE CAVITY. THE TISSUE WAS REMOVED MANUALLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10372789 ↗
• MalfunctionAug 6, 2020Material Rupture; Material Rupture

  THIS FACILITY IS CONVERTING TO OUR BAGS. THIS WAS THE 1ST TIME THIS SURGEON HAS USED OUR BAGS. WHEN HE PULLED THE GALLBLADDER OUT OF THE PORT W/ MODERATE/STRONG FORCE THE BAG BURST. HE DID EVERYTHING CORRECTLY AS I WITNESSED. HE WAS IN-SERVICED ON THIS PRODUCT AND I WAS THERE TO WALK HIM THROUGH THE PROPER USE OF THIS TISSUE BAG. THE BAG WAS NOT PUNCTURED BY ANY INSTRUMENTS. THE BAG SEEMED TO TEAR AT THE CINCH STRING AREA OPENING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10372677 ↗
• MalfunctionAug 6, 2020Material Rupture; Material Rupture

  WHILE PERFORMING A OOPHORECTOMY, THE DOCTOR WAS REMOVING THE SPECIMEN WHEN THE BAG TORE AT THE SEAM. THE BAG WAS EASILY REMOVED, THE SPECIMEN WAS STUCK IN THE PORT OPENING. THE SPECIMEN WAS REMOVED WITH FORCEPS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10372601 ↗
• MalfunctionAug 4, 2020Material Rupture; Material Rupture

  AVERAGE GALL BLADDER, ROUTINE CASE. NOTHING OF SIGNIFICANCE TO NOTE ABOUT PROCEDURE. SHOULD HAVE BEEN AN EASY EXTRACTION OF SPECIMEN. SURGEON WIDENED INCISION TO ACCOMMODATE THE BAG/SPECIMEN AS IT STARTED TO STRETCH IMMEDIATELY. SURGEON WANTED TO AVOID A BREAK, SO HE WIDENED THE INCISINO A SECOND TIME AND WIDENED THE SURGICAL SITE WITH KELLY STYLE INSTRUMENT. AFTER A VERY SHORT TIME, AND MINIMAL EFFORT TO EXTRACT BAG/SPECIMEN THE BAG RIPPED FROM THE DISTAL TIP UP TO ABOUT 2 INCHES. SEE PICTURES OF STRETCHED BAG WITH LARGE TORN OPENING. SURGEON STATED FIRMLY THAT HE "WANTED THESE BAGS OUT OF HIS OR"- HE CALLED THE CRD BY THE TIME I ARRIVED AT HER OFFICE TO RELAY THE SAME STATEMENT. (SURGEON ALSO NOTED PRIOR TO EXTRACTION THAT THE BAG WOULD NOT CLOSE ALL THE WAY WITH THE CINCH CORD WHICH I DID OBSERVE AND ALSO OBSERVED 1ST HAND SEVERAL TIMES IN MY IN-SERVICE DEMOS WITH SEVERAL DIFFERENT SAMPLE BAGS).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10362742 ↗
• MalfunctionAug 4, 2020Material Rupture; Material Rupture

  AVERAGE GALL BLADDER, ROUTINE CASE. NOTHING OF SIGNIFICANCE TO NOTE ABOUT PROCEDURE. SHOULD HAVE BEEN AN EASY EXTRACTION OF SPECIMEN. AFTER MINIMAL EFFORT TO EXTRACT BAGGED SAMPLE BY THE SENIOR RESIDENT HE EXPRESSED CONCERN TO A SECOND DOCTOR THAT THE BAG FELT AS IF IT WOULD NOT HOLD. THE SECOND DOCTOR TOOK OVER, WIDENED THE SURGICAL SITE AND AS SOON AS HE BEGAN TO EXTRACT THE BAG/SPECIMEN, THE TIP BURST AT VERY DISTAL TIP. POST CASE DISCUSSION, THE FIRST DOCTOR SAID HE HAS BEEN IN SEVERAL CASES WITH THE GENICON BAG AND THE GENICON BAG "STRETCHES"- SAID THE OTHER BAGS DON'T STRETCH. HE SAID HE HAS LEARNED FROM HIS OTHER CASES THAT THIS "STRETCH" CAN GIVE A FALSE SENSE OF SECURITY IN THAT IT FEELS (TACTILE FEEDBACK) AS THOUGH YOU ARE MAKING PROGRESS IN THE EXTRACTION BUT REALLY YOU ARE JUST STRETCHING THE BAG UNTIL IT BURSTS. THE SECOND DOCTOR ADDED THAT OTHER BAGS (COMPETITOR) DO NOT STRETCH EVER. THAT IF THEY DO GET A TEAR OR BURST IT IS DUE TO EXTREMELY LARGE SPECIMEN AND SURGEON NOT TAKING THE STEPS TO ASPIRATE, REMOVE LARGE STONES SEPARATELY AND TO WIDEN THE SITE. THIS WAS NOT ONE OF THOSE CASES- SAID THIS WAS A FIRM STONE BUT AVERAGE SIZE SPECIMEN AND THE SITE WAS WIDENED. (PR

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10362740 ↗
• MalfunctionAug 4, 2020Material Rupture; Material Rupture

  ROUTINE LAPAROSCOPIC CHOLECYSTECTOMY. DOCTOR PLACED THE GALLBLADDER IN THE SPECIMEN BAG, CINCHED BAG, AND BEGAN THE REMOVAL OUT OF THE PORT SITE/SURGICAL INCISION SITE. HE ENCOUNTERED OBVIOUS RESISTANCE. HE (I HAD A CLEAR FIELD OF VIEW ON THE LARGE STORTZ HD MONITOR) USED HIS KELLYS TO STRETCH THE OPENING AND PULLED. WHEN THAT DID NOT WORK, HE USED THE SURGICAL BLADE TO WIDEN THE SITE. AS HE DID THIS IT APPEARED TO ME HE COULD POSSIBLY HAVE NICKED THE BAG WHILE PULLING IT OUT AT THE SAME TIME HE WIDENED THE INCISION. THE SPECIMEN REMAINED IN THE BAG (MINUS SOME BILE AND FLUID) AND THE BAG WITH SPECIMEN WERE SUCCESSFULLY REMOVED FROM THE PATIENT. AT THE TIME OF THE BAG TEAR, THE SURGEON YELLED THAT THE BAG BURST AND ASKED ME WHY MY BAG BURST. I COMMENTED THAT IT IS A STRONG BAG AND SHOULD NOT HAVE TORN, BUT THAT ITS STILL POLY - AND WILL RIP WITH ENOUGH FORCE AND THEN ASKED HIM IF HE BY CHANCE NICKED THE BAG WITH THE BLADE UPON EXTRACTION. HE DID NOT COMMENT FURTHER, HOWEVER HIS PA APPROACHED ME AFTER THE CASE EXITING THE SUITE AND COMMENTED THAT SHE WAS SHOCKED I EVEN SUGGESTED HE HIT THE BAG WITH THE INSTRUMENT AND THAT HE DOES THOUSANDS OF LAP CHOLE'S AND DOES THEM THE SAME WAY E

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10361350 ↗
• MalfunctionAug 4, 2020Material Rupture; Material Rupture

  I MET WITH DOCTOR AND REVIEWED THE BAG WITH HIM - HE DID HANDS-ON AND SAID IT LOOKED FINE. I WAS AVAILABLE ON 3/25-3/29, FOR DOCTOR'S CASES, HOWEVER THIS CASE WAS PUSHED AND I WAS NOT MADE AWARE OF THE NEW DATE AND TIME AND WAS NOT PRESENT DUE TO GENICON EVALUATIONS AT OTHER FACILITIES.. DOCTOR DID ONE OTHER CASE WITH THE BAG AND IT WORKED AS EXPECTED. I WAS TOLD BY THE CRD THAT AFTER A DIFFERENT DOCTOR HAD A TEAR (DESCRIBED IN (B)(4)), THAT THIS DOCTOR ALSO HAD A SIMILAR TEAR - AT THE SEAM TOWARD THE BOTTOM OR POINT OF THE BAG. NOTE: I HAVE BEEN PRESENT FOR 4 ADDITIONAL CASES SINCE THIS OCCURRENCE AND THE BAG WORKED WELL, HOWEVER I HAVE NOT SPOKE TO DR. HIPP AT THIS TIME AND WILL DO SO WHEN HE RETURNS. ((B)(4)). IT SHOULD BE NOTED THAT THERE WERE TWO (2) ADDITIONAL COMPLAINTS INCLUDED AS PART OF THE ORIGINAL COMPLAINT RECORD. THIS COMPLAINT RECORD WAS ADDENDED TO FOCUS ON PRODUCT EXPERIENCE REPORT (B)(4). COMPLAINT (B)(4) WAS INITIATED TO ADDRESS P(B)(4) WAS INITIATED TO ADDRESS (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10361349 ↗