FDA Adverse Event
Injury
Summary report: N
OLYMPUS
MDR report key: 306782
·
Received November 29, 2000
Report
- Report Number
- 8010047-2000-00093
- Event Type
- Injury
- Date Received
- November 29, 2000
- Report Date
- October 30, 2000
- Manufacturer
- THE OLYMPUS OPTICAL CO. LTD.
- Product Code
- FDF
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
COMPLAINT DESCRIPTION: A HOSP CLINICAL SYSTEMS ENGINEER REPORTED THAT PERFORATION OF THE COLON OCCURRED DURING A COLONOSCOPY PROCEDURE. THE ENGINEER MENTIONED THAT SURGERY FOR REPAIR OF THE COLON WAS PERFORMED THE SAME DAY; THE PT IS RECOVERING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OLYMPUS | COLONOSCOPE | FDF | THE OLYMPUS OPTICAL CO. LTD. | CF-100L | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |