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 Date 12/11/2014

Event Type  No Answer Provided  

Event Description

Doctor (b)(6) (general surgeon) in (b)(6) had a pt that retained a capsule years ago and last may had emergency surgery.According additional information since (b)(6) 2014: doctor (b)(6) called back and said the pt had the ce procedure done back in (b)(6) 2011.The pt had surgery to have the capsule removed in (b)(6) of 2014.

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 of 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: PILLCAM SB2 CAPSULE
• Type of Device: PILLCAM SB2 CAPSULE
• Manufacturer (Section D): GIVEN IMAGING LTD; hermon building, new industrial; p.o. box 258; yokneam 2069 2; IS 20692
• MDR Report Key: 4395722
• MDR Text Key: 5364185
• Report Number: 9710107-2014-00281
• 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: 12/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2014
• 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: FGS-0179
• Device Lot Number: NOT AVAIALBLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• 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