MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-05-02 for SMARTPILL GI MONITORING SYSTEM PH.P CAPSULE 50100100 manufactured by The Smartpill Corporation.
[3025047]
Pt searched for motility on the internet and found that lancaster gastroenterology performs the smartpill test. Before administering the smartpill, the physician repeated a ct scan because the pt? S symptoms were suggestive of an obstruction rather than a motility disorder. The test came back negative again. The doctor administered the smart pill and it became stuck in the small bowel. When the smartpill failed to pass in 3 weeks (being tracked with x-rays) a bowel prep was administered that successfully propelled it to pass. No additional symptoms were experienced while the smartpill was stuck. After passage a ct with enterography (which looks for small bowel loops) was administered and came back negative. They did an olympus video capsule which observed a lesion in the distal prox ileum. This finding prompted an exploratory laporatomy which resulted in finding a carcinoma of the small bowel (a very rare small bowel cancer). Physician was very wary of initial radiologic results because he couldn? T believe the ct scan was normal, but his test was also normal. Unless he had performed a wireless motility capsule he would not have found the cancer.
Patient Sequence No: 1, Text Type: D, B5
[10268497]
Smart pill sales person became aware of adverse event while visiting customer site: (b)(6).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1320877-2012-00001 |
| MDR Report Key | 2822298 |
| Report Source | 07 |
| Date Received | 2012-05-02 |
| Date of Report | 2012-05-01 |
| Date of Event | 2011-05-10 |
| Date Mfgr Received | 2012-02-17 |
| Date Added to Maude | 2012-11-08 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR RONALD BRANDT |
| Manufacturer Street | 847 MAIN ST. |
| Manufacturer City | BUFFALO NY 142031109 |
| Manufacturer Country | US |
| Manufacturer Postal | 142031109 |
| Manufacturer Phone | 7168820701 |
| Manufacturer G1 | THE SMARTPILL CORPORATION |
| Manufacturer Street | 847 MAIN ST. |
| Manufacturer City | BUFFALO NY 14203110 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 14203 1109 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMARTPILL GI MONITORING SYSTEM |
| Generic Name | GASTROINTESTINAL MOTILITY CAPSULE |
| Product Code | NYV |
| Date Received | 2012-05-02 |
| Model Number | PH.P CAPSULE |
| Catalog Number | 50100100 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THE SMARTPILL CORPORATION |
| Manufacturer Address | 847 MAIN ST. BUFFALO NY 14203110 US 14203 1109 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-05-02 |