MAUDE Adverse Event Report: GIVEN LTD (ISRAEL) PILLCAM SB3 CAPSULE 1-PK; SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE

Model Number FGS-0391

Device Problem Failure To Adhere Or Bond (1031)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

According to the reporter, a procedure was ongoing when the capsule was not found anymore.They took capsule out of stomach and it couldn't be found by the physician anymore.They used a 2nd capsule and that capsule worked fine.

• Brand Name: PILLCAM SB3 CAPSULE 1-PK
• Type of Device: SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE
• Manufacturer (Section D): GIVEN LTD (ISRAEL); 2 hacarmel st.; new industrial pob 258,; yoqneam ; IS
• Manufacturer (Section G): GIVEN LTD (ISRAEL); 2 hacarmel st.; new industrial pob 258,; yoqneam ; IS
• Manufacturer Contact: sharon murphy ; 195 mcdermott st; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6100411
• MDR Text Key: 59808215
• Report Number: 9710107-2016-01090
• Device Sequence Number: 1
• Product Code: NEZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K123864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FGS-0391
• Device Catalogue Number: FGS-0391
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/25/2016
• 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