None 400498Recalls & reported problems
Intuitive Surgical, Inc. · 8MM ENDOSCOPE STERILIZATION TRAY · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00886874115848), received between Mar 7, 2024 and Dec 11, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Material Deformation” (2 reports).
1 FDA recall record name this device's identifier.
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.
Reports received per month
Recalls naming this device
- Dec 19, 2019Terminated
Small but detectable holes in the sterilization wrap used with the firm's 8 mm endoscope sterilization trays and handheld camera sterilization trays could lead to a potential breach of sterility and risk of infection. Certain features on the trays with handling and storage may cause these holes.
Z-2328-2020 · Root cause: Device Design · FDA record ↗
Most reported problems
Device problems
- Material Deformation2
Patient problems
- Unspecified Tissue Injury2
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 11, 2024Material Deformation; Material Deformation
IT WAS REPORTED THAT DURING CENTRAL PROCESSING, WHILE PLACING AN ENDOSCOPE INTO A STAINLESS-STEEL REPROCESSING TRAY, A BURR ON THE UNDERSIDE OF THE TRAY CUT A STAFF MEMBER¿S FINGER, CAUSING BLEEDING. IT IS UNKNOWN HOW MUCH BLEEDING OCCURRED; HOWEVER, THE BLEEDING WAS RESOLVED BY APPLYING A BAND AID. THE TRAY HAD BEEN IN CIRCULATION PRIOR TO THE REPORTED EVENT; AND TO PREVENT A RECURRENCE OF THE EVENT, THE BURR WAS FILED OFF THE TRAY.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury
MAUDE report 20902088 ↗InjuryMar 7, 2024Material Deformation; Material Deformation
REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.
Patient problems: Unspecified Tissue Injury
MAUDE report 18862192 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.