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

Model Number FGS-0391

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the pillcam remained in patient esophagus for a large portion of the pillcam video recording.There was no confirmation whether or not the capsule was excreted.No reported patient harm.This is being reported out of an abundance of caution.

Manufacturer Narrative

(b)(4).Physician dr.(b)(6) confirmed that the patient had no adverse events.Also confirmed that capsule is no longer in patient's body.

Manufacturer Narrative

(b)(4).

• 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 ; 540 oakmead parkway; sunnyvale, CA 94085
• MDR Report Key: 5237342
• MDR Text Key: 31646425
• Report Number: 9710107-2015-05041
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FGS-0391
• Device Catalogue Number: FGS-0391
• Device Lot Number: 27947U
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/03/2015
• 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): Other