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 2017-09-18 for PILLCAM? SB 2 CAPSULE, 1-PACK FGS-0179 manufactured by Given Imaging Ltd., Yoqneam.
[86487081]
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[86487082]
According to the reporter, a patient with crohn's colitis underwent a pillcam procedure, and five months later presented in the emergency room with severe abdominal pain and clinical signs of suspected intestinal obstruction. An x-ray and ct revealed a dilated bowel down to the sigmoid colon where a stricture was suspected. It was also found that the capsule was retained in the cecum. It was noted that the patient was in poor general condition and surgery was considered to be too risky, so the patient was treated with a self-expanding metal stent with the intention to perform surgery within two weeks. The placement of the stent was successful and the obstruction was decompressed. However, two days later the patient presented again with intestinal obstruction. An x-ray demonstrated that the colon was dilated from the cecum to the sigmoid colon, where the capsule was observed to be trapped in the metal stent. The patient underwent an emergency hartmann's procedure and recovered uneventfully.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710107-2017-05487 |
| MDR Report Key | 6872964 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-09-18 |
| Date of Report | 2017-09-12 |
| Date Mfgr Received | 2017-09-12 |
| Date Added to Maude | 2017-09-18 |
| 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 | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 2034925297 |
| 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 | PILLCAM? SB 2 CAPSULE, 1-PACK |
| Generic Name | CAMERA, STILL, SURGICAL |
| Product Code | FTT |
| Date Received | 2017-09-18 |
| Model Number | FGS-0179 |
| Catalog Number | FGS-0179 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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. Other; 2. Required No Informationntervention | 2017-09-18 |