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Amalgatome SD Pneumatic Hose X101004Recalls & reported problems

Exsurco Medical, Inc. · Pneumatic Hose ASD · Class 1

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00810006780000), received between Dec 14, 2021 and Dec 14, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Burst Container or Vessel” (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 18, 2026.

Most reported problems

Device problems

  • Burst Container or Vessel1

Patient problems

  • Crushing Injury1

Recent adverse event reports

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

  • InjuryDec 14, 2021Burst Container or Vessel

    EXSURCO REPRESENTATIVE RECEIVED THE CALL ABOUT THEIR SD HOSE ALLEGEDLY BURSTING IN THE OPERATING ROOM FROM (B)(6), HE GAVE THE VP OF SALES CONTACT INFORMATION TO FOLLOW UP. VP OF SALES SPOKE TO (B)(6), SHE EXPLAINED THE FOLLOWING EVENTS:THE SCRUB TECH ASSEMBLED THE DEVICE AND TESTED THE ASD AND THEN PASSED THE DEVICE TO THE SURGEON WHO TESTED IT AND THE HOSE AT THAT TIME ALLEGEDLY BURST. A MEDICAL STUDENT WITH IN THE STERILE FIELD WAS ALLEGEDLY HIT IN THE NECK (BROKE SKIN) WITH A PIECE OF RUBBER FROM THE HOSE BURST. NO INJURY WAS REPORTED TO THE PATIENT. AN ADDITIONAL EMAIL FROM EXSURCO REPRESENTATIVE WAS SENT TO (B)(6) TO GATHER ADDITIONAL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED FROM (B)(6): DR. (B)(6) WAS THE SURGEON OPERATING AND WAS TRAINED ON THE DEVICE. THE NITROGEN WAS SET AT 130 PSI DURING USE OF THE DEVICE, VERSUS THE RECOMMENDED 100 PSI. THIS WAS NOT THE FIRST TIME THE SURGICAL TECH ASSEMBLED THE DEVICE. THIS IS A FREQUENT USER. THE SERIAL NUMBER OF THE HOSE IS (B)(4). THERE WAS APPROXIMATELY A 20 MINUTE PROCEDURE DELAY. A BACK UP DERMATOME WAS PULLED AND USED. THE MEDICAL STUDENT IS DOING OKAY, WAS CHECKED AND RESUMED BACK TO WORK. IT IS UNCLEAR IF THE MEDICA

    Patient problems: Crushing Injury

    MAUDE report 13005860 ↗

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Sources and updates

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