ARTHREX

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-16 for ARTHREX manufactured by Arthrex.

Event Text Entries

[97700541] During a laparoscopic assisted surgical procedure, an arthrex camera light source was much darker than usual and patient organs and bleeding site were unable to be visualized. Light source camera and cord were replaced with identical arthrex equipment and similar issues continued. Sufficient light was temporarily available and enabled procedure to be completed without any patient harm. Procedure was prolonged due to the equipment issues.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5074601
• MDR Report Key: 7199663
• Date Received: 2018-01-16
• Date of Report: 2018-01-12
• Date of Event: 2018-01-11
• Date Added to Maude: 2018-01-17
• 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
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• 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: 0

• Brand Name: ARTHREX
• Generic Name: CAMERA
• Product Code: KQM
• Date Received: 2018-01-16
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 0
• Device Event Key: 0
• Manufacturer: ARTHREX
• Manufacturer Address: VAIL CO 81657 US 81657

Device Sequence Number: 1

• Brand Name: ARTHREX
• Generic Name: CAMERA
• Product Code: LLZ
• Date Received: 2018-01-16
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ARTHREX
• Manufacturer Address: VAIL CO 81657 US 81657

Patients

Patient Number	Treatment	Outcome	Date
1	0		2018-01-16