NAKAO 00230ARecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 20653405054129), received between Aug 30, 2017 and Feb 28, 2020 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Break” (4 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.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 28, 2020Material Integrity Problem; Material Integrity Problem

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE 00230A DEVICE WAS BEING USED DURING THE REMOVAL OF A GASTROSTOMY TUBE VIA THE UPPER ESOPHAGEAL SPHINCTER ON (B)(6) 2020 WHEN THE NET BROKE UPON OPENING IN THE ESOPHAGUS. A SECOND DEVICE WAS USED AND IS REPORTED TO HAVE BROKEN. THE CAUSE OF THE BREAKAGE IS NOT KNOWN BY THE REPORTER. THERE WAS NO FRAGMENTATION FROM THE DEVICE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AFTER A 15-MINUTE DELAY USING ANOTHER SAME DEVICE. THERE WAS NO IMPACT TO THE PATIENT OR THE USER. 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 9769301 ↗
• MalfunctionSep 27, 2019Material Puncture/Hole; Material Twisted/Bent; Material Puncture/Hole; Material Twisted/Bent

  ON BEHALF OF THE CUSTOMER, THE CONMED SALES REPRESENTATIVE REPORTED AN ISSUE WITH THE SPIDER-NET RETRIEVAL BAGS, ITEM # 00230A, LOT 201907221. IT WAS REPORTED THAT ON (B)(6) 2019, "PRODUCT WAS USED IN AN UPPER ENDOSCOPY FOR A FOOD IMPACTION. THE NETTING RIPPED AND THE WIRE BENT. " IT IS INDICATED THAT THERE WAS NO IMPACT OR INJURY TO THE PATIENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 3-MINUTE DELAY BY USING AN ALTERNATE DEVICE. ADDITIONAL INFORMATION OBTAINED CLARIFIES THAT THE DOCTOR WAS TRYING TO REMOVE FOOD AND THE NETTING BROKE AND WIRE BENT AFTER SECURING THE FOOD BOLUS. IT IS BELIEVED THAT NO PIECE OF THE SPIDER-NET DETACHED OR FELL OFF THE DEVICE BACK INTO THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF PREVIOUS MDR FILINGS FOR SIMILAR INCIDENTS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9130883 ↗
• MalfunctionApr 4, 2019Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE 00230A, STANDARD NET 230L 10 PACK, DEVICE NET RIPPED AND THERE WAS NO PATIENT OR USER INJURY. FURTHER ASSESSMENT INFORMATION WAS REQUESTED; HOWEVER, THE REPORTER RESPONDED THAT THEY HAVE ADVISED ALL THE INFORMATION THEY CAN. NO FURTHER INFORMATION REGARDING THIS EVENT WAS AVAILABLE. 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 8483660 ↗
• MalfunctionApr 4, 2019Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE 00230A, STANDARD NET 230L 10 PACK, DEVICE NET RIPPED AND THERE WAS NO PATIENT OR USER INJURY. FURTHER ASSESSMENT INFORMATION WAS REQUESTED; HOWEVER, THE REPORTER RESPONDED THAT THEY HAVE ADVISED ALL THE INFORMATION THEY CAN. NO FURTHER INFORMATION REGARDING THIS EVENT WAS AVAILABLE. 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 8483650 ↗
• InjuryApr 1, 2019Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE 00230A, STANDARD NET 230L, 10 PACK, DEVICE "WHEN THE PIECES OF POLYP WERE IN THE NETS, THE NET APPEARED TO START TO DISINTEGRATE AND THEN FELL OFF THE WIRE. NO, THEY DID NOT KEEP THE NETS. PART OF IT DID COME OFF, WHEN I (ACCOUNT CONTACT) WENT INTO THE PROCEDURE ROOM YOU COULD SEE SOME OF THE FIBERS ADHERING TO THE POLYP WHICH WAS STILL IN THE COLON". FURTHER INFORMATION WAS REQUESTED; HOWEVER, THE SALES REPRESENTATIVE ADVISED THE ACCOUNT WISHED TO HAVE NO FURTHER CONTACT. IT IS UNKNOWN IF ALL COMPONENTS WERE REMOVED FROM THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO THE UNKNOWN RETRIEVAL OF ALL COMPONENTS OF THE DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8471167 ↗
• MalfunctionMar 27, 2019Fracture; Fracture

  THE CUSTOMER REPORTED THAT 00230A, STANDARD NET 230L 10 PACK, DEVICE WAS BEING USED DURING AN EGD (ESOPHAGOGASTRODUODENOSCOPY) WITH DILATION ON (B)(6) 2019 WHEN "THE DEVICE RUPTURED UPON REMOVAL AT OR AROUND THE TOP OF THE ESOPHAGUS WHICH WAS CONCERNING FOR THE ASPIRATION OF THE NET AND THE FOREIGN BODY. AFTER DETERMINING THE FOREIGN BODY MIGRATED BACK TO THE STOMACH, A SECOND NET AND (SECOND) ATTEMPT WAS MADE BUT THE PATIENT WAS NOT TOLERATING THE PROCEDURE WELL AND IT WAS ABORTED. THE PATIENT DID NOT HAVE ANY SIGN OF ASPIRATION OR BREATHING DIFFICULTY". FURTHER ASSESSMENT FROM THE REPORTER FOUND THAT THE REASON THE PATIENT WAS NOT TOLERATING THE PROCEDURE WELL WAS NOT DIRECTLY DUE TO THE DEVICE BUT INSTEAD THE PATIENT WAS COUGHING AND BECOMING RESTLESS; HOWEVER, THE PATIENT WAS STABLE. WHEN THE DEVICE WAS REMOVED FROM THE SCOPE A HOLE IN THE NET WAS FOUND. THE FOREIGN BODY MAY NOT HAVE BEEN "SMOOTH"; HOWEVER, IT WAS NOT CONSIDERED "SHARP". THIS EVENT CAUSED ~5-MINUTE DELAY. IT WAS FELT BY THE REPORTER THAT THERE WERE NO FRAGMENTS FROM THE DEVICE; THEREFORE, THERE WERE NO FRAGMENTS TO RETRIEVE. THERE WAS NO REPORT OF MEDICAL INTERVENTION OR EXTENDED HOSPITAL STAY FOR THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8455983 ↗
• MalfunctionApr 9, 2018Break; Break

  THE DISTRIBUTOR REPORTED ON BEHALF OF THE USER FACILITY THAT THE 00230A STANDARD NET WAS USED AND FOUND TO BE BROKEN. TO DATE, ADDITIONAL INFORMATION REGARDING CURRENT PATIENT STATUS AND PROCEDURE HAS NOT BEEN MADE AVAILABLE. THIS REPORT IS BEING RAISED ON THE BASIS OF A REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY WITH RECURRENCE.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 7407944 ↗
• MalfunctionJan 8, 2018Break; Break

  THE CONMED REPRESENTATIVE REPORTED ON BEHALF OF THE USER FACILITY THAT DURING AN ENDOSCOPIC PROCEDURE, THE 00230A SPIDER BAG BROKE. TO DATE, NO ADDITIONAL INFORMATION REGARDING THE PATIENT OR EVENT HAS BEEN MADE AVAILABLE. NO PATIENT INJURY WAS REPORTED. THIS INCIDENT IS RAISED ON THE BASIS OF A REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY WITH RECURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7173476 ↗
• MalfunctionJan 8, 2018Break; Break

  THE CONMED REPRESENTATIVE REPORTED ON BEHALF OF THE USER FACILITY THAT DURING AN ENDOSCOPIC PROCEDURE, THE 00230A SPIDER BAG BROKE. TO DATE, NO ADDITIONAL INFORMATION REGARDING THE PATIENT OR EVENT HAS BEEN MADE AVAILABLE. NO PATIENT INJURY WAS REPORTED. THIS INCIDENT IS RAISED ON THE BASIS OF A REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY WITH RECURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7173468 ↗
• MalfunctionJan 5, 2018Break; Break

  THE CONMED REPRESENTATIVE REPORTED ON BEHALF OF THE USER FACILITY THAT DURING AN ENDOSCOPIC PROCEDURE, THE 00230A SPIDER BAG BROKE. TO DATE, NO ADDITIONAL INFORMATION REGARDING THE PROCEDURE OR SURGICAL DELAYS HAS BEEN MADE AVAILABLE. NO PATIENT INJURY WAS REPORTED. THIS INCIDENT IS RAISED ON THE BASIS OF A REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY WITH RECURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7169604 ↗
• MalfunctionAug 30, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE USER FACILITY REPORTED A 00230A SPECIMEN BAG BROKE DURING THE REMOVAL OF A FOOD BOLUS. THIS CAUSED A FIVE MINUTE SURGICAL DELAY AND A SECOND NET FROM THE SAME LOT WAS USED TO COMPLETE THE SURGERY SUCCESSFULLY. THERE WAS NO PATIENT INJURY OR ISSUES REPORTED. THE DEVICE WAS DISCARDED AT THE FACILITY IN THE MAIN O.R.; THEREFORE, IT WILL NOT BE RETURNED FOR EVALUATION. ADDITIONAL PATIENT INFORMATION WAS NOT ABLE TO BE OBTAINED. THIS INCIDENT WILL BE REPORTED AS A DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY WITH RECURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6829673 ↗