Amalgatome SD 4-inch Cutting Head X100969Recalls & reported problems
Exsurco Medical, Inc. · Blade Head 4" ASD; Excision ring blade head · 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 00810006780048), received between Apr 23, 2021 and Apr 23, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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
- Improper or Incorrect Procedure or Method1
- Material Puncture/Hole1
- Mechanical Problem1
- Use of Device Problem1
Patient problems
- Partial thickness (Second Degree) Burn1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 23, 2021Mechanical Problem; Material Puncture/Hole; Use of Device Problem; Improper or Incorrect Procedure or Method
EXSURCO SURGICAL APPLICATIONS SPECIALIST (ESAS) WAS THE HOSPITAL ON (B)(6) 2021. IN DISCUSSION WITH DR (B)(6), THEY HAD A LARGE BURN FOR EXCISION AND ELECTED NOT USE THE AMALGATOME FOR DEBRIDEMENT ON A PREVIOUS CASE BUT USED THE VERSAJET INSTEAD. SHE ADVISED THAT SHE IS NOT COMFORTABLE USING THE AMALGATOME AND WILL OPT TO USE ANYTHING BUT THE AMALGATOME GIVEN THE OPPORTUNITY. EXSURCO SURGICAL APPLICATIONS SPECIALIST WAS GOING SET UP A LAB FOR ADDITIONAL TRAINING WITH HER TO GET HER MORE COMFORTABLE USING THE ASD. SHE ADVISED THAT SHE WOULD BE AVAILABLE UNTIL MID-APRIL OR LATER. EXSURCO SURGICAL APPLICATIONS SPECIALIST LEFT FACILITY. THREE HOURS LATER, EXSURCO SURGICAL APPLICATIONS SPECIALIST RECEIVED A CALL FROM THE BURN OR, ON ANOTHER CASE THAT DR. (B)(6)WAS ATTENDING, STATING THAT THEY NEED ME BECAUSE SOMETHING IS WRONG WITH THE ASD AND IT HAD ALLEGEDLY "CHEWED UP TWO GRAFTS AND THEY ARE NOT USABLE." EXSURCO SURGICAL APPLICATIONS SPECIALIST ADVISED THEM TO SEND THE UNIT BACK TO EXSURCO FOR INSPECTION. EXSURCO SURGICAL APPLICATIONS SPECIALIST RECEIVED INFORMATION AFTER THE FACT REGARDING GRAFTS WERE UNUSABLE. EXSURCO SURGICAL APPLICATIONS SPECIALIST CONFIRMED THAT THIS FACILITY US
Patient problems: Partial thickness (Second Degree) Burn
MAUDE report 11712594 ↗
Other Dermatome devices
- Dermatome 00-8801-001-00Zimmer Orthopaedic Surgical Products, Inc. · Dermatome1 recall631 reports
- Dermatome 00-8821-001-00Zimmer Orthopaedic Surgical Products, Inc. · Dermatome614 reports
- Dermatome 88710100Zimmer Orthopaedic Surgical Products, Inc. · DERMATOME242 reports
- Dermatome 00-8800-000-10Zimmer Orthopaedic Surgical Products, Inc. · Dermatome1 recall109 reports
- NA 00-8851-002-06Zimmer Orthopaedic Surgical Products, Inc. · DERMATOME22 reports
- ACCULAN 3TI GA670Aesculap AG · Dermatome6 reports
- Air Dermatome 00-8801-002-00Zimmer Orthopaedic Surgical Products, Inc. · Dermatome5 reports
- NA 00-8851-002-05Zimmer Orthopaedic Surgical Products, Inc. · DERMATOME3 reports
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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