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ERAGON MODULAR 8393292Recalls & reported problems

Richard Wolf GmbH · GRASP. FORCEPS INSERT Ø 5MM atraumatic, jaw with wavy edge, jaw length 26mm, for SL 330mm, single 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 04055207015988), received between Oct 18, 2018 and Oct 18, 2018 — classified as 1 malfunction.

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

  • Break1
  • Detachment of Device or Device Component1

Patient problems

  • Device Embedded In Tissue or Plaque1
  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 18, 2018Break; Detachment of Device or Device Component

    USER FACILITY RETURNED THE DEVICE TO RWMIC ON (B)(6) 2018 AND THE EVALUATION WAS COMPLETED ON (B)(6) 2018. THE DEVICE APPEARED TO USED AND BROKEN - THE PULL ROD WAS BROKEN DISTALLY AT THE TRANSITION TO THE JOINT PART. THE REPORTED CONDITION WAS VERIFIED USING VISUAL TESTING. THE ROOT CAUSE WAS DETERMINED TO BE USER HANDLING ISSUES, CAUSE OF THE SITUATION WAS DUE TO A MECHANICAL OVERLOAD. EXCESSIVE FORCE DURING GRIPPING CAUSED THE DISTAL END OF THE PULL TO BREAK. NO MANUFACTURING DEFECTS WERE IDENTIFIED.

    Patient problems: Device Embedded In Tissue or Plaque; No Consequences Or Impact To Patient

    MAUDE report 7982482 ↗

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Sources and updates

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