NA 111748Recalls & reported problems
Mako Surgical Corp. · END EFFECTOR DOUBLE ANGLE COLLET · Class 1
Data updated Oct 13, 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 00848486002565), received between Feb 19, 2019 and Jun 21, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Computer Software 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Computer Software Problem1
- Detachment of Device or Device Component1
- Insufficient Device Problem Information1
- Non Reproducible Results1
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 21, 2019Computer Software Problem; Insufficient Device Problem Information; Computer Software Problem; Insufficient Device Problem Information
THE BURR DID NOT ENGAGE WHEN THE SURGEON PRESSED THE TRIGGER ON THE ANSPACH. I RESET THE CUTTER AND NO POWER TO THE ANSPACH. I RESET THE ARM SOFTWARE AND NO POWER TO THE ANSPACH. I CHANGED THE ANSPACH AND RAN A BURR STATUS CHECK WITH THE TRIGGER AND THE FOOT PEDAL AND FAILED BOTH. I DID A HARD SHUT DOWN, RE-HOMED THE ROBOT, DID ANOTHER BURR STATUS CHECK. I FAIL BOTH THE TRIGGER AND FOOT PEDAL. I FINALLY SWAPPED OUT THE END EFFECTOR AND RAN ANOTHER BURR STATUS CHECK, HOMED THE ROBOT AND PASSED THE BURR STATUS CHECK. WE SUCCESSFULLY COMPLETED THE CASE. CASE TYPE: PKA. SURGICAL DELAY: 20-30 MINUTES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8724594 ↗MalfunctionFeb 19, 2019Detachment of Device or Device Component; Non Reproducible Results; Detachment of Device or Device Component; Non Reproducible Results
DURING THE PKA CASE EARLIER TODAY, THE SMALL AND LARGE COLLET NUT WOULD NOT HOLD THE ANSPACH BURR IN PLACE. THIS MALFUNCTION CAUSED THE ANSPACH TO MOVE FROM THE ORIGINAL REGISTRATION POSITION AND SUBSEQUENTLY NOT PASS A REGISTRATION CHECK. IN ORDER TO RECTIFY THIS ISSUE, WE HAD TO OPEN THE OTHER PKA TRAY THAT LIVES AT (B)(6) AND USE THE SMALL AND LARGE COLLET NUT FROM THE SET TO COMPLETE THE CASE. CASE TYPE: PKA.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8351855 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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