Operon OT 8601065Recalls & reported problems
Berchtold Holding GmbH · Berchtold Surgical Table, D 860 · Class 1
All models of Operon (11)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327170078), received between Nov 15, 2023 and Dec 23, 2025 — classified as 1 death, 1 malfunction.
The most frequently reported specific device problem is “Unintended Collision” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Unintended Collision1
- Use of Device Problem1
Patient problems
- Heart Failure/Congestive Heart Failure1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 23, 2025Unintended Collision; Unintended Collision
IT WAS REPORTED THAT THE TABLE RAISED UP 6 INCHES OFF THE FLOOR DURING A PROCEDURE. BASED ON IMAGES RECEIVED, THE TABLE COLLIDED WITH ANOTHER DEVICE. THERE WERE NO REPORTED INJURIES OR ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23882935 ↗DeathNov 15, 2023Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT DURING PROCEDURE THE TABLE'S SLIDE FUNCTION WAS NOT MOVING IN POSITION. IT WAS FURTHER STATED IN THE SURGEON'S POST OPERATION REPORT THAT THE TABLE WAS UNABLE TO SLIDE CORRECTLY CAUSING DELAYS IN OPEN HEART PROCEDURE AND PATIENT PASSED AWAY. THE REPORTED DELAY WAS 1 HOUR. ADDITIONAL INFORMATION DETERMINED THAT DURING THE OPEN-HEART SURGERY, MEDICAL COMPLICATIONS OCCURRED WHICH NECESSITATED REPOSITIONING THE PATIENT TO ADD AN IMAGING EXTENSION ACCESSORY. THE SURGEON CLAIMED THE TABLE FUNCTIONALITY LED TO THIS DELAY IN PROCEDURE WHICH WAS A CONTRIBUTING FACTOR TO A PATIENT¿S DEATH.
Patient problems: Heart Failure/Congestive Heart Failure
MAUDE report 18145298 ↗
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- ALLEN 107003Hill-Rom, Inc. · Table, operating-room, electrical1 recall9 reports
- Head-Positioning accessories 1739994Baxter Medical Systems GmbH + Co. KG · TABLE, OPERATING-ROOM, ELECTRICAL1 recall1 report
- TS 7500 2067886Baxter Medical Systems GmbH + Co. KG · TABLE, OPERATING-ROOM, ELECTRICAL1 recall0 reports
- TS 7500 1717021Baxter Medical Systems GmbH + Co. KG · TABLE, OPERATING-ROOM, ELECTRICAL1 recall0 reports
- TS 7500 4091000Baxter Medical Systems GmbH + Co. KG · TABLE, OPERATING-ROOM, ELECTRICAL1 recall0 reports
- ALLEN 107003Hill-Rom, Inc. · Table, operating-room, electrical1 recall0 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 13, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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