MAUDE Adverse Event Report: ACCUTOME, INC B-SCAN PLUS; ULTRAASONIC PULSED ECHO IMAGING SYSTEM

Model Number 24-6100

Device Problems Mechanical Problem (1384); Device Fell (4014)

Patient Problem Eye Pain (4467)

Event Date 05/28/2021

Event Type  Injury  

Manufacturer Narrative

Additional details: customer said they saw crack in probe.

Event Description

Customer reported that the oil had leaked out of the probe and onto a patient's cornea and caused significant discomfort.They applied ointment and patched the patient's eye and asked for the person to return next day for evaluation, and they haven't been able to reach the patient since.The patient complained burning as if being scratched.They said they saw a "crack" on the probe.

• Brand Name: B-SCAN PLUS
• Type of Device: ULTRAASONIC PULSED ECHO IMAGING SYSTEM
• Manufacturer (Section D): ACCUTOME, INC; 3222 phoenixville pike; malvern PA 19355
• Manufacturer (Section G): ACCUTOME, INC.; 3222 phoenixville pike; malvern PA 19355
• Manufacturer Contact: molly ehret ; 3222 phoenixville pike; malvern, PA 19355 ; 8005235620
• MDR Report Key: 12128364
• MDR Text Key: 263225754
• Report Number: 2521877-2021-00001
• Device Sequence Number: 1
• Product Code: IYO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070943
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Administrator/Supervisor
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 06/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 24-6100
• Device Catalogue Number: 24-6100
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2021
• Date Manufacturer Received: 05/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other