NA 8735685Recalls & reported problems
Richard Wolf GmbH · FLEX. GRASP. FORCEPS 5FR WL 550MM double action, TL 700 mm, non-dismantling, reusable · Class 1
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04055207020265), received between Jul 19, 2022 and Jul 19, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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.
Recalls naming this device
- Mar 24, 2023Open, Classified
Potentially unable to open forceps jaws when the endoscope shaft is bent by about 90 degrees. If, in addition, the proximal forceps shaft is bent, the forceps can no longer be opened or restrictions begin even with a slight bending of the endoscope.
Z-1424-2023 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Deformation Due to Compressive Stress1
- Material Twisted/Bent1
Patient problems
- 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 19, 2022Deformation Due to Compressive Stress; Material Twisted/Bent; Deformation Due to Compressive Stress; Material Twisted/Bent
RICHARD WOLF GMBH COMPLAINT REFERENCE (B)(4). IT WAS REPORTED TO RICHARD WOLF GMBH. (RWGMBH) THAT "WHEN TRYING TO REMOVE A DJ SPLINT(CATHETER), THE FORCEPS COULD NO LONGER BE TURNED OR OPENED. THE OPERATION WAS ABORTED. THE PATIENT DID NOT SUFFER ANY CONSEQUENCES." RWGMBH AWARENESS DATE, (B)(6) 2022.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15058126 ↗
Other FORCEPS, BIOPSY, NON-ELECTRIC devices
- Radial Jaw 4 M00513410Boston Scientific Corporation · FORCEPS, BIOPSY, NON-ELECTRIC1 recall24 reports
- Radial Jaw 4 M00513330Boston Scientific Corporation · FORCEPS, BIOPSY, NON-ELECTRIC1 recall19 reports
- Radial Jaw 4 M00513400Boston Scientific Corporation · FORCEPS, BIOPSY, NON-ELECTRIC1 recall16 reports
- NA 8736685Richard Wolf GmbH · FORCEPS, BIOPSY, NON-ELECTRIC1 recall15 reports
- NA 828051Richard Wolf GmbH · FORCEPS, BIOPSY, NON-ELECTRIC1 recall6 reports
- Radial Jaw 4 M00513320Boston Scientific Corporation · FORCEPS, BIOPSY, NON-ELECTRIC1 recall3 reports
- Radial Jaw 4 M00513360Boston Scientific Corporation · FORCEPS, BIOPSY, NON-ELECTRIC1 recall2 reports
- NA 829051Richard Wolf GmbH · FORCEPS, BIOPSY, NON-ELECTRIC1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.