MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 03 report with the FDA on 2009-11-19 for PILLCAM SB CAPSULE NOT AVAILABLE manufactured by Given Imaging, Ltd..
[21320194]
This incident has been published in cases journal, acute small bowel perforation after wireless capsule endoscopy in a patient with crohn's disease: a case report dhavan a parikhl*, janak a parikh, gregory c albers and charles f chandler. The investigators concluded that: "wireless capsule endoscopy remains the preferred endoscopic imaging method of the small bowel. This case illustrates the importance of appropriate patient selection and evaluation of functional patency of the small bowel prior to wireless capsule endoscopy, especially with the growing role of this procedure in the evaluation of inflammatory bowel disease. "
Patient Sequence No: 1, Text Type: N, H10
[21429455]
As reported in the publication: "a male pt with a presumed quiescent history of crohn's disease presented to the emergency department in a septic state 48 hours after a wireless capsule endoscopy procedure complaining of abdominal pain, distension, and frequent emesis. A computed tomography scan of the abdomen was suggestive of small bowel perforation and ischemic enteritis. The patient was adequately resuscitated and taken to the operating room for an ileocecectomy and extensive resection of the small bowel. Pathology of the resected specimen revealed an ileal stricture and associated necrotizing ileitis, and a perforation just proximal to the stricture. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710107-2009-00214 |
| MDR Report Key | 1545867 |
| Report Source | 03 |
| Date Received | 2009-11-19 |
| Date of Report | 2009-11-19 |
| Date Added to Maude | 2009-12-02 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PILLCAM SB CAPSULE |
| Generic Name | PILLCAM SB CAPSULE |
| Product Code | NSI |
| Date Received | 2009-11-19 |
| Model Number | NOT AVAILABLE |
| Catalog Number | NOT AVAILABLE |
| Lot Number | NOT AVAILABLE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GIVEN IMAGING, LTD. |
| Manufacturer Address | HERMON BLG, NEW INDUSTR. PK PO BOX 258 YOKNEAM 20692 IS 20692 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2009-11-19 |