MAUDE Adverse Event Report: GIVEN IMAGING LTD SMARTPILL CAPSULE; GASTROINTESTINAL MOTILITY SYSTEM, CAPSULE

Model Number FGS-0503

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Stenosis (2263)

Event Date 11/23/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4) initial report date: 12/23/2015.The sample has been requested but to date the incident sample has not been received for evaluation.If the sample is received or if additional information pertinent to the incident is obtained a follow-up report will be submitted.

Event Description

Physician reported patient with retained smartpill capsule.Patient ingested the capsule on (b)(6) 2015 and was hospitalized (b)(6) 2015 after experiencing severe abdominal pains for 1-2 days.Xray and ct scan confirmed capsule retained in small bowel proximal to a stricture.Patient was not known to have a stricture prior to the procedure.Patient underwent surgery to remove the capsule and the stricture.Physician reported a distal ileal pelvic adhesion from a previous radiation surgery which may have caused the stricture.Patient is doing well.

• Brand Name: SMARTPILL CAPSULE
• Type of Device: GASTROINTESTINAL MOTILITY SYSTEM, CAPSULE
• Manufacturer (Section D): GIVEN IMAGING LTD; 2 hacarmel st.; p.o. box 258; new industrial park, yoqneam 20692 ; IS 20692
• Manufacturer (Section G): GIVEN IMAGING LTD; 2 hacarmel st.; p.o. box 258; new industrial park, yoqneam 20692 ; IS 20692
• Manufacturer Contact: sharon murphy ; 540 oakmead parkway; sunnyvale, CA 94085 ; 2034925267
• MDR Report Key: 5324970
• MDR Text Key: 34289681
• Report Number: 9710107-2015-00327
• Device Sequence Number: 1
• Product Code: NYV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092342
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/02/2015

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?: No
• Device Operator: Physician
• Device Expiration Date: 01/15/2017
• Device Model Number: FGS-0503
• Device Catalogue Number: FGS-0503
• Device Lot Number: 28851P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2015
• Initial Date FDA Received: 12/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention