CAPSULE ENDOSCOPY DELIVERY DEVICE 1518070

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-07 for CAPSULE ENDOSCOPY DELIVERY DEVICE 1518070 manufactured by Us Endoscopy.

Event Text Entries

[57316116] Yellow tip missing from 3 (total 3 missing yellow tips) capsule endoscopy devices. No harm to patient.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5065327
• MDR Report Key: 6020536
• Date Received: 2016-10-07
• Date of Report: 2016-10-07
• Date of Event: 2016-09-26
• Date Added to Maude: 2016-10-12
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Sequence Number: 1

• Brand Name: CAPSULE ENDOSCOPY DELIVERY DEVICE
• Generic Name: CAPSULE ENDOSCOPY DELIVERY DEVICE
• Product Code: PGD
• Date Received: 2016-10-07
• Catalog Number: 1518070
• Lot Number: 1518070 AND 1613400
• Device Expiration Date: 2017-11-01
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: US ENDOSCOPY
• Manufacturer Address: MENTOR OH 44060 US 44060

Device Sequence Number: 2

• Brand Name: CAPSULE ENDOSCOPY DELIVERY DEVICE
• Generic Name: CAPSULE ENDOSCOPY DELIVERY DEVICE
• Product Code: PGD
• Date Received: 2016-10-07
• Catalog Number: 1518070
• Lot Number: 1518070 AND 1613400
• Device Expiration Date: 2017-11-01
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: *
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: US ENDOSCOPY
• Manufacturer Address: MENTOR OH 44060 US 44060

Device Sequence Number: 3

• Brand Name: CAPSULE ENDOSCOPY DELIVERY DEVICE
• Generic Name: CAPSULE ENDOSCOPY DELIVERY DEVICE
• Product Code: PGD
• Date Received: 2016-10-07
• Catalog Number: 1518070
• Lot Number: 1518070 AND 1613400
• Device Expiration Date: 2017-11-01
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: *
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: US ENDOSCOPY
• Manufacturer Address: MENTOR OH 44060 US 44060

Patients

Patient Number	Treatment	Outcome	Date
1	0		2016-10-07