OLYMPUS AMERICA, INC.

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-10-21 for OLYMPUS AMERICA, INC. manufactured by Olympus America, Inc..

Event Text Entries

[1739111] On (b)(6) 2010, my wife, (b)(6) had an endoscopic capsule camera given orally to examine general digestive problems that she has been encountering for some time. On (b)(6) 2010, she entered (b)(6) er with a suspected tia. An x-ray noted the above capsule - mfg by olympus america, inc - lodged in her lower colon. A definitive mri could not be done concerning the tia for fear of magnetic effects on the capsule and internal damages. On (b)(6) 2010, mrs (b)(6) underwent an upper gi at (b)(6) hosp and the test determined that the capsule was still in the same position in the lower colon--the ileus i believe. Mrs (b)(6) is too fragile to undergo surgery at this time for removal so, we are looking for advice from all concerned, particularly olympus as to frequency of such incidents, time elapsed on such lodgings, the possibility of the capsule dissolving over time and will any component parts harm the system if it does dissolve or begin to erode? Since it has been lodged for about 10 months, are there ill-effects we should watch for? Also, when was this capsule last tested by fda tracking procedures? Another problem for her is, should she have another tia, an mri cannot be used to further examine for stroke, etc because of the dramatic magnetic effect. Is a ct scan equally definitive? It certainly seems we are in between a rock and a hard place.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5017904
• MDR Report Key: 1884909
• Date Received: 2010-10-21
• Date of Report: 2010-10-21
• Date of Event: 2010-01-20
• Date Added to Maude: 2010-11-09
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: OLYMPUS AMERICA, INC.
• Generic Name: ENDOSCOPY CAPSULE CAMERA
• Product Code: NSI
• Date Received: 2010-10-21
• Lot Number: UNK
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: OLYMPUS AMERICA, INC.
• Manufacturer Address: 3500 CORPORATE PKWY. CENTER VALLEY PA 18034061 US 18034 0610

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2010-10-21