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Soft/Traction Clamp Inserts A0803Recalls & reported problems

Applied Medical Resources Corporation · Clamp Inserts · Class 2

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 00607915113391), received between Jul 7, 2016 and Jul 7, 2016 — classified as 1 malfunction.

The most frequently reported specific device problem is “Failure To Adhere Or Bond” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Failure To Adhere Or Bond1

Patient problems

  • 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.

  • MalfunctionJul 7, 2016Failure To Adhere Or Bond; Failure To Adhere Or Bond

    DISCOVERED PRIOR TO SURGERY - "INSERTS ARE NOT STAYING ON THE CLAMPS. MEDLINE COMPLAINT #: (B)(4), MEDLINE PART #: 05945." FROM MEDLINE: "WE WERE NOTIFIED OF A COMPLAINT FROM A CUSTOMER STATING THAT THE INSERTS ARE FALLING OF THE FOGARTY CLAMPS. THE SAMPLES WERE RECEIVED FOR INVESTIGATION AND WITHOUT THE CLAMPS THE REPORTED CONCERN COULD NOT BE CONFIRMED. THE RETURNED SAMPLES WERE MEASURED AND COMPARED TO THE SAMPLES THAT WERE PULLED FROM OUR INVENTORY. BOTH SETS CONTAIN THE SAME MEASUREMENT. WE WOULD LIKE YOUR HELP TO DETERMINE IF THE SAMPLES ARE TO YOUR SPECIFICATIONS. IF YOU WOULD LIKE THE SAMPLES RETURN FOR INVESTIGATION PLEASE PROVIDE A CALL TAG. PLEASE REFERENCE BELOW COMPLAINT NUMBER IN FUTURE COMMUNICATION." ADDITIONAL INFORMATION RECEIVED JUNE 7, 2016: "Q. CAN YOU PLEASE PROVIDE US WITH THE CUSTOMER INFORMATION? A. UNFORTUNATELY, THAT IS PROPRIETARY INFORMATION. Q. PLEASE CONFIRM THE QUANTITY INVOLVED. WHEN YOU SAY ?BOTH SETS,? DO YOU MEAN 4 TOTAL? A. THERE IS A TOTAL OF 4 TWO THAT THE CUSTOMER RETURNED AND TWO THAT WE PULLED FROM OUR STOCK TO COMPARE THE MEASUREMENTS. Q. PLEASE CONFIRM THE DATE THAT THE INCIDENT OCCURRED. A. IT WAS REPORTED ON (B)(6) 2016. Q. WHEN WAS THE

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 5776829 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.