MAUDE Adverse Event Report: GIVEN IMAGING LTD., YOQNEAM UNKNOWN PILLCAM; SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE

Model Number UNKNOWN PILLCAM

Device Problem Entrapment of Device (1212)

Patient Problem Aspiration/Inhalation (1725)

Event Date 04/12/2018

Event Type  Injury  

Manufacturer Narrative

Title: aspiration of a small bowel video capsule: a rare complication.Source: thomas skouras, 2018.Date published: 04 12 2018.If information is provided in the future, a supplemental report will be issued.

Event Description

According to literature source of study performed, 30 minutes after ingestion of the capsule, the real-time viewer suggested that the location was in the patient's oropharynx.After 30 minutes of inspection, it was indicated that the retention was in the pharyngeal tract of the patient.The capsule location was viewed via gastroscopy and was placed endoscopically in the duodenum.No repeat procedure was needed.There was no further injury to the patient.

Manufacturer Narrative

Correction: (model#, catalog#).If information is provided in the future, a supplemental report will be issued.

• Brand Name: UNKNOWN PILLCAM
• Type of Device: SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE
• 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: 8320012
• MDR Text Key: 135512427
• Report Number: 9710107-2019-00056
• Device Sequence Number: 1
• Product Code: NEZ
• UDI-Device Identifier: 07290101361404
• UDI-Public: 07290101361404
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K101250
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN PILLCAM
• Device Catalogue Number: UNKNOWN PILLCAM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/16/2019
• Initial Date FDA Received: 02/08/2019
• Supplement Dates Manufacturer Received: 04/29/2019
• Supplement Dates FDA Received: 04/29/2019
• 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): Other
• Patient Age: 72 YR