FDA Adverse Event
Injury
Summary report: N
MANOSCAN 3D AR
MDR report key: 2572297
·
Received May 8, 2012
Report
- Report Number
- 9710107-2012-01374
- Event Type
- Injury
- Date Received
- May 8, 2012
- Report Date
- May 6, 2012
- Manufacturer
- GIVEN IMAGING LTD.
- Product Code
- FFX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IS
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ALTHOUGH IT IS A KNOWN COMPLICATION IN THE MEDICAL COMMUNITY, IT IS A VERY RARE EVENT IN OUR RECORDS. THERE ARE PRIOR REPORTS OF RECTAL PERFORATION FROM SIMILAR PROCEDURES. PLEASE SEE ATTACHED TWO RELATED ARTICLES.
Description of Event or Problem · 1
THE CUSTOMER REPORTED OF A PT WITH A SMALL PERFORATION IN THE PROXIMAL RECTUM FROM AN ENDOANAL MANOMETRY PROCEDURE, PERFORMED WITH THE MANOSCAN 3D AR SYSTEM. THE CUSTOMER THINKS THE EVENT MIGHT HAVE OCCURRED DUE TO THE POINTY OR SHARP TIP OF THE ANORECTAL CATHETER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MANOSCAN 3D AR | MANOSCAN 3D AR | FFX | GIVEN IMAGING LTD. | 3D PROBE | NOT AVAILABLE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |