MAUDE Adverse Event Report: GIVEN IMAGING LTD. PILLCAM SB2 CAPSULE

Model Number PILLCAM SB2 CAPSULE

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Obstruction/Occlusion (2422)

Event Type  Injury  

Event Description

Case study of endoscopic capsule impaction causing acute small intestinal obstruction in a patient with crohn's disease (cd), having obscure gastrointestinal bleeding.A (b)(6)year old female presented with features of acute small bowel obstruction 2 days after capsule endoscopy elsewhere for the evaluation of intermittent bleeding per rectum and iron deficiency anemia.Patient underwent an exploratory laparotomy with right hemicolectomy for the diseased ileocecal region which mimicked malignancy.The capsule was found to be impacted in the strictured lumen of the terminal ileum.Post-operative histopathological examination revealed it to be crohn's disease.

• Brand Name: PILLCAM SB2 CAPSULE
• Type of Device: PILLCAM SB2 CAPSULE
• Manufacturer (Section D): GIVEN IMAGING LTD.; hermon building; new industrial park, po box 258; yokneam 20692 ; IS 20692
• MDR Report Key: 3836073
• MDR Text Key: 4396185
• Report Number: 9710107-2014-00069
• Device Sequence Number: 1
• Product Code: NEZ
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K101250
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PILLCAM SB2 CAPSULE
• Device Catalogue Number: NOT AVAILABLE
• Device Lot Number: NOT AVAILABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR