FDA Adverse Event Malfunction Summary report: N

ALIGNRT PLUS

MDR report key: 12306592 · Received August 11, 2021

Report

Report Number: 3004832819-2021-90002
Event Type: Malfunction
Date Received: August 11, 2021
Date of Event: July 21, 2021
Report Date: August 9, 2021
Manufacturer: VISION RT LTD.
Product Code: IYE
UDI-DI: 05056190500573
PMA / PMN Number: K203387
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

DURING SYSTEM INSTALLATION, THE USER MOVED THE CALIBRATION PLATE AND HIS HAND WAS GRAZED. HE DID NOT REQUIRE MEDICAL ATTENTION. THERE WAS NO SERIOUS OUTCOME. THE MANUFACTURER INSPECTED THE COMPONENT INVOLVED IN THE INCIDENT AND FOUND A SHARP EDGE ON ONE CORNER. THE MANUFACTURER ALSO INSPECTED THE SAME TYPE OF COMPONENTS CURRENTLY IN STOCK AND FOUND THAT THE SAME PROBLEM WAS PRESENT IN MULTIPLE UNITS. THE ROOT CAUSE WAS FOUND TO BE AN INADEQUATE PRODUCT SPECIFICATION FOR THIS COMPONENT: THE MANUFACTURER DID NOT SPECIFY THAT THIS COMPONENT IS TO BE FREE FROM SHARP EDGES OR BURRS. THE MANUFACTURER INSPECTED THE COMPONENT INVOLVED IN THE INCIDENT AND THE SAME COMPONENT IN STOCK AT THE MANUFACTURING SITE. SHARPS EDGES AND BURRS WERE REMOVED WHERE FOUND. THE PRODUCT SPECIFICATION AND INSPECTION WORK INSTRUCTION WERE UPDATED TO SPECIFY NO SHARP EDGES AND BURRS. CUSTOMER SUPPORT PERSONNEL HAVE BEEN INSTRUCTED TO VISUALLY INSPECT THIS COMPONENT . RISK MANAGEMENT HAS BEEN ADDRESSED. THIS COMPLETES THE REQUIRED ACTIONS. NO RECALL/CORRECTION INITIATED AS NOT REQUIRED.

Description of Event or Problem · 1

DURING SYSTEM INSTALLATION, THE USER MOVED THE CALIBRATION PLATE AND HIS HAND WAS GRAZED. HE DID NOT REQUIRE MEDICAL ATTENTION. THERE WAS NO SERIOUS OUTCOME.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1204963	ALIGNRT PLUS	CALIBRATION PLATE	IYE	VISION RT LTD.	VD0577		05056190500573

Patients

Seq	Age	Sex	Outcome	Treatment
1