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

Model Number UNKNOWN-BRAVO

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Awareness during Anaesthesia (1707); Aspiration/Inhalation (1725); Pain (1994); Ulcer (2274); Sore Throat (2396); Foreign Body In Patient (2687)

Event Date 12/06/2018

Event Type  Injury  

Manufacturer Narrative

Title retrieval of a esophageal ph monitoring probe dislodged into the laryngopharynx: a case report source cases-anesthesia-analgesia.Org, volume 13, 2019 (1-3) article number: 1 date of publication: 6 december 2018.If information is provided in the future, a supplemental report will be issued.

Event Description

According to literature source of study performed on december 2018, they had a probe dislodgement during esophagogastroduodenoscopy under monitored anesthesia care.Upon withdrawal of the endoscope to confirm proper probe placement, the probe was not visualized.It was not found in the stomach or duodenum and the endoscope was removed to view the laryngeal pharynx.The probe was found in the pyriform fossa near the glottic opening.The patient was placed in the trendelenburg position and general anesthesia was induced with additional propofol and succinylcholine and an endotracheal tube was placed using a video laryngoscope.Intubation of the patient minimized the risk of aspiration and facilitated removal without surgical consultation.Magill forceps were used to remove the device from the laryngopharynx without trauma to the pharynx or glottis.The patient was allowed to recover in the post anesthesia care unit for an additional hour before discharge home.The patient described a mild sore throat as expected from laryngoscopy and intubation, but reported no hoarseness, dysphagia, coughing, or myalgia from succinylcholine.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to literature source of study performed on (b)(6)2018, the patient with chronic back pain, opioid dependence, atypical gastroesophageal reflux disease without frank reflux, and gastric ulcers without helicobacter pylori infection was presented for es ophagogastroduodenoscopy which they had a probe dislodgement under monitored anesthesia care.Upon withdrawal of the endoscope to confirm proper probe placement, the probe was not visualized.It was not found in the stomach or duodenum and the endoscope was removed to view the laryngeal pharynx.The probe was found in the pyriform fossa near the glottic opening.The patient was placed in the trendelenburg position and general anesthesia was induced with additional propofol and succinylcholine and an endotracheal tube was placed using a video laryngoscope.Intubation of the patient minimized the risk of aspiration and facilitated removal without surgical consultation.Magill forceps were used to remove the device from the laryngopharynx without trauma to the pharynx or glottis.The patient was allowed to recover in the post anesthesia care unit for an additional hour before discharge home.The patient described a mild sore throat as expected from laryngoscopy and intubation, but reported no hoarseness, dysphagia, coughing, or myalgia from succinylcholine.

• Brand Name: UNKNOWN-BRAVO
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692
• Manufacturer (Section G): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692
• Manufacturer Contact: amy beeman ; 161 cheshire lane, suite 100; plymouth, MN 55441 ; 7632104064
• MDR Report Key: 8907823
• MDR Text Key: 155000089
• Report Number: 9710107-2019-00376
• Device Sequence Number: 1
• Product Code: FFT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: UNKNOWN-BRAVO
• Device Catalogue Number: UNKNOWN-BRAVO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2019
• 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
• Patient Age: 59 YR