MAUDE Adverse Event Report: GIVEN IMAGING INC. / MEDTRONIC GIVEN ENDOSCOPY CAPSULE; SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS CAPSULE

Lot Number 40501X

Device Problem No Display/Image (1183)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 08/29/2018

Event Type  malfunction  

Event Description

Endoscopy capsule was connected to recorder, images were transmitted.The pt swallowed the capsule.While the capsule was in the mouth, through esophagus images continued, once the capsule entered the stomach images ceased to transmit.Given imaging was contacted, troubleshooting was attempted without success.Given imaging determined that the capsule was defective or malfunctioned.Capsule was passed through normal bowel movement.No repeat studies performed.Dates of use: (b)(6) 2018.Diagnosis or reason for use: lower gi bleeding.The product was not compounded; the product was not over-the-counter.

• Brand Name: GIVEN ENDOSCOPY CAPSULE
• Type of Device: SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS CAPSULE
• Manufacturer (Section D): GIVEN IMAGING INC. / MEDTRONIC
• MDR Report Key: 7872878
• MDR Text Key: 120413613
• Report Number: MW5079791
• Device Sequence Number: 1
• Product Code: NEZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 40501X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 74