Amalgatome SD Hand Piece (Drive Unit) X101016Recalls & reported problems
Exsurco Medical, Inc. · Drive Unit 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 00810006780017), received between May 24, 2021 and May 24, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Output Problem” (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
- Output Problem1
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.
InjuryMay 24, 2021Output Problem
CUSTOMER ALLEGED THAT THE ASD IS LEAVING CIRCULAR MARKS ON THE EXCISION SITE. THE BLADE WAS CHANGED AND DONOR SITE WAS TAKEN WITH THE SAME RESULTS. DR. (B)(6) IS REQUESTING A LOANER WHILE WE EVALUATE THEIR UNIT. HE IS A SKILLED USER WITH THE DEVICE AND USES IT 3-4 TIMES A DAY. THIS IS THE FIRST TIME HE HAS SEEN THIS ON A PATIENT. SOME OF THE GRAFT TAKEN WAS USABLE, 50% OF THE GRAFT TAKEN WAS DISCARDED. THE EXCISION RINGS (BLADES) WERE NOT KEPT OR SENT BACK FOR REVIEW. THE EXCISION WAS FROM THE PATIENTS RIGHT ABDOMEN MIDDLE QUADRANT AND THE GRAFT WAS RIGHT POSTERIOR THIGH. SERIAL # (B)(4) OF HANDPIECE AND 4" EXCISION RINGS (BLADES) LOT: X-0000000000019. EXSURCO MEDICAL REQUESTED ADDITIONAL INFORMATION FROM FACILITY (3 ATTEMPTS). ASKED FOR STATUS ON THE PATIENT AND ON THE GRAFT USABILITY. IN ADDITION, EXSURCO SALES WAS ON SITE WEEK OF (B)(6) 2021. PLAN FOR VISIT IS TO INTRODUCE CUSTOMER TO THE TRAINING APPLICATION. EXSURCO REPRESENTATIVE WAS ABLE TO SPEAK WITH DR. (B)(6) ON (B)(6) 2021. HE APOLOGIZED FOR NOT RESPONDING TO THE EMAIL YET AS HE WAS ON VACATION ALL LAST WEEK. HE PROVIDED THE ANSWERS TO THE FOLLOWING QUESTIONS: WHY WASN'T THE GRAFT USED/DISCARDED? DESCRIPTION OF GRAFT (SH
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11872964 ↗
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- 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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