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

Model Number PILLCAM PATENCY CAP

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Obstruction/Occlusion (2422)

Event Date 05/20/2014

Event Type  Injury  

Event Description

On (b)(6) 2014, a patient swallowed patency capsule and started to have some obstructive symptoms, the patient was transported to er for examination.Given imaging tried to communicate with the patient's to follow up but only at (b)(6) 2014 additional information that the patient had surgery at the hospital to remove the capsule was provided.Further information from (b)(6) 2014 that the patient has a tumorous cancer that was blocking the capsule from being passed.Surgery was performed and tumor was removed.Capsule is no longer retained.

Manufacturer Narrative

Patency capsules is an accessory to the pillcam video capsule and its intended use is to verify adequate patency of the gastrointestinal tract prior to administration of the pillcam video capsule in patients with known or suspected strictures.The patient has a tumorous cancer that was blocking the capsule form being passed.Surgery was performed and tumor was removed.Surgery was performed to remove the cancerous tumor and was not because of the capsule.(b)(4).

• Brand Name: PILLCAM PATENCY CAPSULE
• Type of Device: PILLCAM PATENCY CAPSULE
• Manufacturer (Section D): GIVEN IMAGING LTD.; po box 258; hermon building industrial park; yokneam 20692 ; IS 20692
• MDR Report Key: 4058232
• MDR Text Key: 16781989
• Report Number: 9710107-2014-00156
• Device Sequence Number: 1
• Product Code: NEZ
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K090557
• 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: 05/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PILLCAM PATENCY CAP
• Device Catalogue Number: FGS-0109
• 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