MAUDE Adverse Event Report: GIVEN IMAGING LTD PILLCAM SB 3 CAPSULE; SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE

Model Number FGS-0501

Device Problem Difficult to Advance (2920)

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

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Customer reported patient with a retained sb3 capsule.Patient underwent procedure on (b)(6) 2016.On (b)(6) 2016 it was confirmed that the capsule was no longer retained, and had passed through a bowel movement.The patient was not harmed.

• Brand Name: PILLCAM SB 3 CAPSULE
• Type of Device: SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, 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: 5511475
• MDR Text Key: 40725840
• Report Number: 9710107-2016-00093
• Device Sequence Number: 1
• Product Code: NEZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: FGS-0501
• Device Catalogue Number: FGS-0501
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/18/2016
• 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): Other