MAUDE Adverse Event Report: GIVEN IMAGING LTD., YOQNEAM PILLCAM® SB 2 CAPSULE, 10-PACK; SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE

Model Number	FGS-0200
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/06/2011
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter, a patient underwent a procedure in 2011, prior to which the patient had a successful patency procedure, and has had the capsule retained within him/her since then.The patient had a barium swallow and small bowel follow through (sbft) for follow-up care for crohn's disease.There was no exacerbation of disease that prompted this recent examination.The examination demonstrated that the capsule remains retained with a slightly dilated loop of the ileum.The reporter states that the capsule appeared to have separated into two components.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: PILLCAM® SB 2 CAPSULE, 10-PACK
• Common Device Name: SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE
• Manufacturer (Section D): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692
• MDR Report Key: 6820004
• Report Number: 9710107-2017-05429
• Device Sequence Number: 19229804
• Product Code: NEZ
• UDI-Device Identifier: 10884521726123
• UDI-Public: 10884521726123
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K101250
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/23/2016
• Device Model Number: FGS-0200
• Device Catalogue Number: FGS-0200
• Device Lot Number: 27765U
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2017
• Initial Date Received by Manufacturer: 08/04/2017
• Supplement Date Received by Manufacturer: 02/01/2018
• Initial Report FDA Received Date: 08/25/2017
• Supplement Report FDA Received Date: 02/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other