ERAGON MODULAR 8393293Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04055207015995), received between Sep 29, 2017 and Apr 20, 2021 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 20, 2021Use of Device Problem; Detachment of Device or Device Component; Use of Device Problem; Detachment of Device or Device Component

  IT WAS REPORTED TO RICHARD WOLF (B)(4): THE CUSTOMER REPORTED THE FOLLOWING INCIDENT TO HEALTH (B)(6). DURING A LAPAROSCOPIC SURGERY, THE WOLF DUAL ACTION BOWEL GRASPER BROKE INSIDE THE PATIENT. THIS OCCURRED DURING ROTATION OF THE INSTRUMENT. THIS RESULTED IN THE PATIENT REQUIRING A LAPAROTOMY TO REMOVE THE INSTRUMENT, AND THE INSTRUMENT BEING DISMANTLED INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11697252 ↗
• MalfunctionJul 22, 2020Mechanical Problem; Mechanical Problem

  ON (B)(6) 2020, RWMIC RECEIVED THE MEDWATCH REPORT # 2700490000-2019-8022 FROM FDA. ON (B)(6) 2020, RWMIC REACHED OUT TO THE INITIAL REPORTER TO RECEIVE ADDITIONAL INFORMATION. IT WAS REPORTED THAT DURING A LAPAROSCOPIC NISSEN WITH DR. WHILE THE LAPAROSCOPIC GRASPER BROKE WHILE BEING USED ON THE PATIENT. ALL THE PIECES WERE RETRIEVED FROM INSIDE THE PATIENT. THE PROCEDURE WAS FINISHED AND THE PATIENT WAS TRANSFERRED TO PACU IN STABLE CONDITION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10307619 ↗
• MalfunctionMay 19, 2020Break; Break

  RICHARD WOLF (B)(4) RECEIVED THE FOLLOWING INFORMATION ON MARCH 05, 2020: ACCORDING TO THE CUSTOMER: JOINT SECTION BROKE OFF DURING THE OPERATION. THE USER WAS ABLE TO COMPLETELY REMOVE THE FORCEPS FROM THE PATIENT AND SENT IT IN FOR INSPECTION. THERE IS WRITTEN CONFIRMATION THAT THE INCIDENT DID NOT LEAD TO A SERIOUS DETERIORATION OF THE PATIENT'S OR THIRD PARTY'S HEALTH, BUT THAT IT DID LEAD TO A 30 MINUTE EXTENSION OF THE OPERATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10073444 ↗
• InjurySep 29, 2017Break; Detachment Of Device Component

  FACILITY CALLED (B)(4), DURING A PROCEDURE, TO REPORT THE DEVICE IN QUESTION BROKE. ONE OF THE GRASPING JAWS BROKE OFF AND FACILITY WAS NOT 100% SURE ALL PARTS OF DEVICE HAD BEEN ACCOUNTED FOR. FACILITY REQUESTED DRAWING OF DEVICE AND INDICATED PATIENT WAS IN PROCESS OF BEING X-RAYED IN AN EFFORT TO ASSURE ALL PARTS WERE REMOVED. NO INJURY TO PATIENT REPORTED. FACILITY HAS NOT SUPPLIED THE LOT # OF DEVICE, THEREFORE THE MANUFACTURER DATE, PURCHASE DATE AND SERVICE DATES ARE UNKNOWN AT THIS TIME. FACILITY HAS PURCHASED (B)(4) SIMILAR DEVICES (ID #8393.293) SINCE FEB2014. THERE HAS BEEN ONE SIMILAR INCIDENT,ON THIS SPECIFIC DEVICE (ID #8393.293), IN THE LAST THREE YEARS (MDR #1418479-2014-00045). FACILITY HAS BEEN CONTACTED TWICE, VIA EMAIL, IN AN EFFORT TO GATHER ADDITIONAL AND MISSING INFORMATION FOR THIS REPORT. NO RESPONSE AS OF 09/29/2017. AS OF 29SEP2017, DEVICE HAS NOT BEEN RETURNED TO (B)(4). DEVICE WILL BE SENT TO MANUFACTURER FOR INVESTIGATION IF AND WHEN IT IS RETURNED TO (B)(4). (B)(4) CONSIDERS THIS MATTER CLOSED. HOWEVER, IN THE EVENT (B)(4) RECEIVES ANY ADDITIONAL INFORMATION, (B)(4) WILL PROVIDE THE MANUFACTURER OF DEVICE WITH THE INFORMATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6906443 ↗