MAUDE Adverse Event Report: GIVEN IMAGING LTD., YOQNEAM BRAVO; ELECTRODE, PH, STOMACH

Model Number FGS-0636

Device Problem Positioning Failure (1158)

Patient Problems Aspiration/Inhalation (1725); Sedation (2368); No Code Available (3191)

Event Date 01/16/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the patient was scheduled for procedure egd (esophagogastroduodenoscopy) with ph capsule placement with anesthesia.The doctor performed and proceeded to deploy the capsule in the esophagus as planned.When endoscope was being withdrawn from patient, it was realized the capsule did not deploy as it should.All of the appropriate steps were followed in order to deploy the capsule and suction equipment that is required for capsule placement was functioning properly.The doctor re-introduced endoscope in attempt to retrieve the capsule and it was found in the patient's airway and due to patient's cough reflex, it ended up in the nasopharynx.Ent was called emergently to assist in retrieving the capsule from the nasopharynx and was eventually successful in the retrieval.Anesthesia had to emergently intubate patient in order to protect airway for retrieval of capsule.

• Brand Name: BRAVO
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692 ; IL 20692
• Manufacturer (Section G): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692 ; IL 20692
• Manufacturer Contact: amy beeman ; 161 cheshire lane, suite 100; plymouth, MN 55441 ; 7632104064
• MDR Report Key: 10623910
• MDR Text Key: 209780656
• Report Number: 9710107-2020-00478
• Device Sequence Number: 1
• Product Code: FFT
• UDI-Device Identifier: 07290101369714
• UDI-Public: 07290101369714
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FGS-0636
• Device Catalogue Number: FGS-0636
• Device Lot Number: 48086F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention