CONVERTORS 29242Recalls & reported problems
Cardinal Health 200, LLC · Laparoscopy Pack · Class 2
- 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 10885380071553), received between Jun 6, 2017 and Jun 6, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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
- Device Contamination with Chemical or Other Material1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 6, 2017Device Contamination with Chemical or Other Material
WHEN OPENING FOR THE CASE, THE SCRUB NURSE NOTED A STAIN ON THE BACK TABLE COVER. INSTRUMENTATION FOR THE CASE HAD ALREADY BEEN PLACED ON THE BACK TABLE SO IT REQUIRED A NEW SET-UP FOR THE CASE CAUSING A DELAYED START TO THE PROCEDURE. THE (B)(6) YEAR OLD PATIENT WAS IN THE PROCESS OF BEING INDUCED SO THE INCIDENT DID EXTEND THE LENGTH OF GENERAL ANESTHESIA EXPOSURE. THE CASE WAS A HYSTEROSCOPY AND D&C.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6616131 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.