MAUDE Adverse Event Report: GIVEN IMAGING GIVEN IMAGING GI PILLCAM; PILLCAM RECORDER & PILLCAM

Lot Number	39980X (PILLCAM)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/14/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Given pillcam and recorder had two episodes where they stopped communicating.A reboot was performed following each failure with the first recording session lasting more than 3 hrs, and the subsequent session lasting more than 1.5 hrs.This resulted in an incomplete/inconclusive test result.Diagnosis or reason for use: endoscopy - colonoscopy."is the product compounded: no, is the product over-the-counter: no.".

• Brand Name: GIVEN IMAGING GI PILLCAM
• Common Device Name: PILLCAM RECORDER & PILLCAM
• Manufacturer (Section D): GIVEN IMAGING
• MDR Report Key: 7613408
• Report Number: MW5077920
• Device Sequence Number: 13893061
• Product Code: PGD
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/15/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Lot Number: 39980X (PILLCAM)
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/18/2018
• 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: Hospitalization
• Patient Age: 66 YR