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

Model Number PLIICAM SB2 CAPSULE

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Obstruction/Occlusion (2422)

Event Date 10/07/2014

Event Type  Injury  

Event Description

A (b)(6) man with anemia was referred to hosp to undergo capsule endoscopy (ce), which revealed small intestinal ulcers.Five months after ce, he returned because of recurrent anemia without abdominal symptoms.Abdonimal x-ray and computed tomography showed capsule retention in the small intestine at the pelvic cavity.The capsule remained at the same place for 7 days.We performed capsule retrieval by spectroscopy assisted surgery with resection of the involved small intestine, including an ilea stricture.Reseated specimen showed double ulcers with different morphologies, an ulcer scar with stricture, and a wide ulcer at the proximal side of the others.Each ulcer had different histopathological findings such as the degree of fibrosis and monocyte infiltration.

Manufacturer Narrative

Given imaging labeling, such as user manual indicate that pillcam sb capsules are contraindicated for use in pts with known or suspected gastrointestinal obstruction, strictures, or fistulas based on the clinical picture or pre procedure testing and profile.Diagnostic tools are available to physicians to assess pts before administration of the pillcam sb capsule including the agile patency system, ct enterography, or mr enterography.

• Brand Name: PLIICAM SB2 CAPSULE
• Type of Device: PLIICAM SB2 CAPSULE
• Manufacturer (Section D): GIVEN IMAGING LTD.; hermon building; new industrial park, po box 258; yokneam 20692 ; IS 20692
• MDR Report Key: 4543391
• MDR Text Key: 5506501
• Report Number: 9710107-2014-00233
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 11/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PLIICAM SB2 CAPSULE
• Device Catalogue Number: FGS-0179
• 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: 50 YR