Soft / Fibra® CLAMP INSERTS G-4550Recalls & reported problems
Applied Medical Resources Corporation · SURGICAL CLAMP INSERTS · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00607915111380), received between Apr 22, 2017 and Apr 22, 2017 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Material Deformation2
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 22, 2017Material Deformation; Material Deformation
EVENT DESCRIPTION: (ON (B)(6) 2017, DURING A PREPARATION): A MEDICAL STAFF TRIED TO ATTACH THE INSERT G4550 TO A CLAMP, HOWEVER; IT DID NOT FIT. ANOTHER PACKAGE OF INSERT WAS OPENED BUT THE MEDICAL STAFF CONFIRMED DEFORMATION AT THE BUTTON. THUS THE MEDICAL STAFF CANCELED TO USE THE SECOND ONE. THIS EVENT DIDN'T AFFECT THE PATIENT. ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM DISTRIBUTOR APRIL 5, 2017 - THE DEFECTS FOR THE G-4550 WERE NOTICED BEFORE THE PROCEDURE. PROCEDURE PERFORMED: UNKNOWN. TYPE OF INTERVENTION: NA. PATIENT STATUS: NO HEALTH DAMAGE WAS REPORTED FOR THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6513685 ↗MalfunctionApr 22, 2017Material Deformation; Material Deformation
EVENT DESCRIPTION: (ON (B)(6) 2017: DURING A PREPARATION), A MEDICAL STAFF TRIED TO ATTACH THE INSERT G4550 TO A CLAMP, HOWEVER; IT DID NOT FIT. ANOTHER PACKAGE OF INSERT WAS OPENED BUT THE MEDICAL STAFF CONFIRMED DEFORMATION AT THE BUTTON. THUS THE MEDICAL STAFF CANCELED TO USE THE SECOND ONE. THIS EVENT DIDN'T AFFECT THE PATIENT. ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM DISTRIBUTOR APRIL 5, 2017 - THE DEFECTS FOR THE G-4550 WERE NOTICED BEFORE THE PROCEDURE. PROCEDURE PERFORMED: UNKNOWN. TYPE OF INTERVENTION: NA. PATIENT STATUS: NO HEALTH DAMAGE WAS REPORTED FOR THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6513684 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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