MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,l report with the FDA on 2020-01-07 for UNKNOWN PILLCAM manufactured by Given Imaging Ltd., Yoqneam.
[174201884]
Title efficacy and safety of extracorporeal shock-waves lithotripsy in biliary and pancreatic stones: a 12-years experience source turk j gastroenterol 2019; 30(suppl 3): s137-s912. September 3, 2019. (b)(4). If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[174201885]
According to literature source of study performed on 2003 to 2018, they performed 633 examinations for the indication of suspected crohn's disease or known crohn's disease with suspected lesions in the small bowel. They used three different capsule systems. The evaluation for capsule endoscopy was after upper and lower gastrointestinal endoscopy and an anamnesis in respect of pain as the leading symptom. Radiology or patency capsule was not mandatory. A patency capsule was used in only 2 patients. Radiological examinations before capsule endoscopy were done in less than 15%. In these 633 examinations, they found significant lesions in the small bowel in more than 36%. Unsuspected retention happened in only 5 patients, two of them needed a surgical intervention because of a scarred stenosis (not diagnosed by cross sectional imaging). For the other 3 patients, the capsule was retrieved by enteroscopy.
Patient Sequence No: 1, Text Type: D, B5
[182655670]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9710107-2020-00021 |
| MDR Report Key | 9559575 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2020-01-07 |
| Date of Report | 2020-01-21 |
| Date of Event | 2019-09-01 |
| Date Mfgr Received | 2020-01-02 |
| Date Added to Maude | 2020-01-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | AMY BEEMAN |
| Manufacturer Street | 161 CHESHIRE LANE, SUITE 100 |
| Manufacturer City | PLYMOUTH MN 55441 |
| Manufacturer Country | US |
| Manufacturer Postal | 55441 |
| Manufacturer Phone | 7632104064 |
| Manufacturer G1 | GIVEN IMAGING LTD., YOQNEAM |
| Manufacturer Street | YETSIRA 13 STREET |
| Manufacturer City | YOQNEAM 20692 |
| Manufacturer Postal Code | 20692 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN PILLCAM |
| Generic Name | SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE |
| Product Code | NEZ |
| Date Received | 2020-01-07 |
| Model Number | UNKNOWN PILLCAM |
| Catalog Number | UNKNOWN PILLCAM |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GIVEN IMAGING LTD., YOQNEAM |
| Manufacturer Address | YETSIRA 13 STREET YOQNEAM 20692 20692 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-07 |