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

Model Number	UNKNOWN PILLCAM
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Aspiration/Inhalation (1725)
Date of Event	04/12/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional Manufacturer Narrative
Correction: (model#, catalog#).If information is provided in the future, a supplemental report will be issued.

• Brand Name: UNKNOWN PILLCAM
• Common Device Name: SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE
• Manufacturer (Section D): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692
• MDR Report Key: 8320012
• Report Number: 9710107-2019-00056
• Device Sequence Number: 16725011
• Product Code: NEZ
• UDI-Device Identifier: 07290101361404
• UDI-Public: 07290101361404
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K101250
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,l
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: UNKNOWN PILLCAM
• Device Catalogue Number: UNKNOWN PILLCAM
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/16/2019
• Supplement Date Received by Manufacturer: 04/29/2019
• Initial Report FDA Received Date: 02/08/2019
• Supplement Report FDA Received Date: 04/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 72 YR