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  No Answer Provided  

Event Description

A customer called on how to copy a video for another physician.The video was for a patient with a retained capsule since (b)(6) 2014.The capsule is report to be in the area near the illogical.The patient recently started reporting pain and was referred to another physician.The patient is not seeing a surgeon to remove the capsule.The account doesn't need any assistance with the capsule remove as the patient is seeing another doctor.

• Brand Name: PILLCAM SB2 CAPSULE
• Type of Device: PILLCAM SB2 CAPSULE
• Manufacturer (Section D): GIVEN IMAGING LTD.; hermon bldg, new industrial park; p.o.box 258; yokneam 2069 2; IS 20692
• MDR Report Key: 4652719
• MDR Text Key: 5678989
• Report Number: 9710107-2015-00056
• Device Sequence Number: 1
• Product Code: NEZ
• Combination Product (y/n): N
• 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: 09/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2015
• 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: FGS-0179
• 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