ERAGON MODULAR 8393190Recalls & reported problems
Richard Wolf GmbH · DEBAKEY FORCEPS-INSERT Ø 5MM atraumatic, jaw length 39mm, for SL 330mm, double action, reusable · Class 2
All models of ERAGON MODULAR (16)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04055207015872), received between Jul 1, 2022 and Jul 1, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
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 16, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Insufficient Device Problem Information1
- No Apparent Adverse Event1
Patient problems
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 1, 2022Detachment of Device or Device Component; No Apparent Adverse Event; Insufficient Device Problem Information; Detachment of Device or Device Component; No Apparent Adverse Event; Insufficient Device Problem Information
RICHARD WOLF GMBH COMPLAINT REFERENCE (B)(4). ON JUNE 14, 2022 RICHARD WOLF GMBH WAS INFORMED ABOUT THE FOLLOWING: DURING LAPAROSCOPIC PROSTATE RESECTION, AFTER INTERNAL ORGAN EXCLUSION WHEN THE DOCTOR REMOVED THE FORCEPS VIA TROCAR, THE JAW PART OF THE INSERT WAS COMPLETELY BROKEN. NO INITIAL INFORMATION OF THE COMPONENT OF THE JAW PART, SUCH AS PIN, IT WAS IMPOSSIBLE TO KNOW ALL BROKEN PARTS WERE COLLECTED. THE USER PERFORMED AN X-RAY BUT COULD NOT CONFIRM IF ANYTHING REMAINED IN THE BODY. THE TREATMENT COULD BE COMPLETED WITH A REPLACEMENT INSTRUMENT. FURTHERMORE; THE USER STATED THAT THERE IS NO HEALTH HAZARD FOR THE PATIENT. RWGMBH AWARENESS DATE, 14-JUN-2022.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 14887648 ↗
Other Laparoscope, general & plastic surgery devices
- HIGH DEFINITION LCD MONITOR OEV262HOlympus Medical Systems Corp. · Laparoscope, general & plastic surgery1,937 reports
- HD AUTOCLAVABLE CAMERA HEAD OTV-S7ProH-HD-12EOlympus Medical Systems Corp. · Laparoscope, general & plastic surgery1,886 reports
- HD AUTOCLAVABLE CAMERA HEAD OTV-S7ProH-HD-10EOlympus Medical Systems Corp. · Laparoscope, general & plastic surgery1,086 reports
- Auto Suture OMS-T10BTCovidien LP · Laparoscope, general & plastic surgery1 recall955 reports
- PDB OMS-PDB1000Covidien LP · Laparoscope, general & plastic surgery859 reports
- VISERA 4K UHD CAMERA CONTROL UNIT OLYMPUS OTV-S400Olympus Medical Systems Corp. · Laparoscope, general & plastic surgery777 reports
- Auto Suture OMS-T10SBCovidien LP · Laparoscope, general & plastic surgery1 recall697 reports
- Spacemaker SMBTTRNDXCovidien LP · Laparoscope, general & plastic surgery590 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page