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

Model Number 50100100

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Patient Problem/Medical Problem (2688)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The investigation cannot confirm the reported defect because the incident sample was not returned for evaluation.  should new information become available, a follow-up report will be submitted.

Event Description

Patient ingested a smartpill capsule on (b)(6), 2015.Patient did not pass capsule after the 5 day study was completed.On (b)(6) 2015 the patient reported that the capsule had not been excreted.(b)(6), 2016 kub was done and the capsule was visualized.Colonoscopy was also done, the capsule was not visualized.Laxatives were given, capsule was not excreted.Enteroscopy with fluoroscopy was done showing visualization of a narrowing.The narrowing was dilated and the capsule was removed during a second enteroscopy.Patient recovered from the procedure and was discharged to home.The customer has not seen the patient since the second enteroscopy.

• 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: 5448522
• MDR Text Key: 38629227
• Report Number: 9710107-2016-00024
• 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: 01/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2016
• 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
• Date Manufacturer Received: 01/20/2016
• 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