GeniStrong 550-000-003Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00877972004004), received between Oct 15, 2017 and Aug 13, 2020 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (2 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2020Material Rupture; Material Rupture

  THE BAGS BROKE DURING USE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10400945 ↗
• MalfunctionAug 12, 2020Material Rupture; Material Rupture

  THE BAGS BROKE DURING USE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10397059 ↗
• MalfunctionJul 7, 2020Material Fragmentation; Material Fragmentation

  SPECIMEN RETRIEVAL BAG BROKE AT ITS SEAM. SURGEON SPENT CONSIDERABLE TIME EXTRACTING, ADDING 1.5 HOUR TO THE CASE.

  Patient problems: No Information

  MAUDE report 10243045 ↗
• MalfunctionJul 7, 2020Material Integrity Problem; Material Integrity Problem

  THE RIP-STOP NYLON STRIP CONTAINING CINCHING STRING CAME DETACHED FROM THE SPECIMEN RETRIEVAL BAG AND POINT OF CONNECTION TO THE BAG. THE SPECIMEN RETRIEVAL BAG FELL INTO PATIENT'S ABDOMEN AND WAS RETRIEVED BY THE SURGEON USING A GRASPER.

  Patient problems: No Information

  MAUDE report 10243044 ↗
• MalfunctionJul 7, 2020Material Integrity Problem; Material Integrity Problem

  DURING A LAP CHOLECTOMY, THE GENICON SPECIMEN BAG WAS USED THROUGH A 12MM LAP PORT. THE GALLBLADDER WAS COLLECTED WITH THE BAG. THE CORRECT TECHNIQUE WAS USED TO CLOSE THE BAG. THE PORT WAS PULLED OUT OF THE PATIENT. THE GENICON BAG WAS BEING PULLED OUT OF THE PATIENT BY THE STRING WHEN IT WAS TORN IN HALF. THE GALLBLADDER HAD SEVERAL SMALL AND LARGE STONES IN IT WHICH THEN WERE SCATTERED BACK INTO THE ABDOMEN OF THE PATIENT AND THROUGHOUT THE LAYERS OF TISSUE OF THE ABDOMINAL WALL. A PICTURE OF THE BROKEN DEVICE INSIDE THE ABDOMEN IS AVAILABLE.

  Patient problems: No Information

  MAUDE report 10243042 ↗
• InjuryAug 28, 2019Difficult to Open or Close

  PER REPORT PROVIDED ON 8/6/2019: "FROM [SALES] REP: DURING A LAP APPENDECTOMY, DR. (B)(6) COULD NOT GET THE SPECIMEN BAG TO CLOSE TIGHTLY AT THE TOP. WHILE REMOVING THE BAG FROM THE PATIENT, SOME OF THE BAGS CONTENTS SPILLED. THE PATIENT LATER DEVELOPED A SURGICAL SITE INFECTION. FROM [HOSPITAL STAFF]: WE NOW HAVE AN INFECTION ON A LAP APPENDECTOMY PATIENT. ALTHOUGH IT IS DIFFICULT TO DETERMINE THE CAUSE, THE SURGEON BELIEVES THE CULPRIT IS SPILLAGE FROM THE RETRIEVAL BAG AS THE BAG WOULD NOT CLOSE APPROPRIATELY. FOR THIS PARTICULAR SURGEON, THIS INFECTION IS HIS FIRST LAP APPENDECTOMY INFECTION."

  Patient problems: Post Operative Wound Infection

  MAUDE report 8939573 ↗
• MalfunctionAug 16, 2019Human-Device Interface Problem; Human-Device Interface Problem

  REFERENCE CUSTOMER DOCUMENT NUMBER PER (B)(4): "DURING THE PROCEDURE THE METAL RING AT THE TOP OF THE BAG PULLED OUT OF THE CHANNEL PREVENTING IT FROM BEING ABLE TO DEPLOY A 2ND TIME. THE SURGEON WAITED FOR ANOTHER BAG TO BE RETRIEVED AND OPENED AND REFUSES TO USE THE BAG AGAIN. I HAVE THE FAILED BAG IN A BIOHAZARD BAG AND IN MY OFFICE ALONG WITH THE OUTSIDE WRAPPER. WE WILL NOT BE MOVING FORWARD WITH THE PMI SPECIMEN RETRIEVABLE BAG. WE DO APPRECIATE YOUR EFFORTS IN PROVIDING THE CASE SUPPORT OVER THE PAST 3 WEEKS." 2ND EMAIL ON 7/2/2019: "WHETHER IT WAS USER ERROR OR NOT - THE PRODUCT FAILED AND WITH THE METAL OUT OF THE BAG CHANNEL - REDEPLOYMENT WAS IMPOSSIBLE AND ANOTHER PRODUCT WAS RETRIEVED AND USED WITHOUT USER ERROR. A PICTURE WAS NOT TAKEN DURING THIS UNPLANNED EMERGENCY CASE. I HAVE THE PRODUCT IN MY OFFICE. UPON MY INSPECTION OF THE BAG, IT APPEARS THAT ONLY 1 OF THE METAL ARMS WAS STICKING OUT THROUGH THE TINY "MANUFACTURED HOLE" IN THE BAG MATERIAL [AT THE MOUTH OF THE BAG, ABOVE THE THREAD]. THE OTHER METAL ARM IS PROPERLY ENCASED WITHIN THE CHANNEL OF THE BAG MATERIAL." ADDITIONAL INFORMATION (HANDWRITTEN NOTE) INCLUDED WITH THE RETUNED DEVICE: "DR. AMR WAS UPSET I

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8903470 ↗
• MalfunctionOct 15, 2017Material Frayed

  MATERIAL FRAYED FROM TETHER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6950584 ↗