MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2016-02-19 for SMARTPILL? CAPSULE, SINGLE 50100100 manufactured by Given Imaging Ltd.
[38629227]
(b)(4). The investigation cannot confirm the reported defect because the incident sample was not returned for evaluation.? Should new information become available, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[38629228]
Patient ingested a smartpill capsule on (b)(6), 2015. Patient did not pass capsule after the 5 day study was completed. On (b)(6) 2015 the patient reported that the capsule had not been excreted. (b)(6), 2016 kub was done and the capsule was visualized. Colonoscopy was also done, the capsule was not visualized. Laxatives were given, capsule was not excreted. Enteroscopy with fluoroscopy was done showing visualization of a narrowing. The narrowing was dilated and the capsule was removed during a second enteroscopy. Patient recovered from the procedure and was discharged to home. The customer has not seen the patient since the second enteroscopy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710107-2016-00024 |
| MDR Report Key | 5448522 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-02-19 |
| Date of Report | 2016-01-20 |
| Date Mfgr Received | 2016-01-20 |
| Date Added to Maude | 2016-02-19 |
| 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 | SHARON MURPHY |
| Manufacturer Street | 540 OAKMEAD PARKWAY |
| Manufacturer City | SUNNYVALE CA 94085 |
| Manufacturer Country | US |
| Manufacturer Postal | 94085 |
| Manufacturer Phone | 2034925267 |
| Manufacturer G1 | GIVEN IMAGING LTD |
| Manufacturer Street | 2 HACARMEL ST. P.O. BOX 258 |
| Manufacturer City | NEW INDUSTRIAL PARK, YOQNEAM 20692 |
| Manufacturer Country | IS |
| Manufacturer Postal Code | 20692 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMARTPILL? CAPSULE, SINGLE |
| Generic Name | GASTROINTESTINAL MOTILITY SYSTEM CAPSULE |
| Product Code | NYV |
| Date Received | 2016-02-19 |
| Model Number | 50100100 |
| Catalog Number | 50100100 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GIVEN IMAGING LTD |
| Manufacturer Address | 2 HACARMEL ST. P.O. BOX 258 NEW INDUSTRIAL PARK, YOQNEAM 20692 IS 20692 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-02-19 |