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

Model Number 50100100

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The 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

It was reported that the capsule was retrieved by an egd procedure.No further information was obtained.

• Brand Name: SMARTPILL CAPSULE, SINGLE
• 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: 5305159
• MDR Text Key: 33699175
• Report Number: 9710107-2015-00302
• 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: Physician
• Type of Report: Initial
• Report Date: 10/26/2014

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 Model Number: 50100100
• Device Catalogue Number: 50100100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/26/2014
• Initial Date FDA Received: 12/16/2015
• 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
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention