MAUDE Adverse Event Report: PUREPOINT LASER; LASER, OPHTHALMIC

Catalog Number 8065750597

Device Problem No Display/Image (1183)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/30/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).

Event Description

A customer reported that before the retinal surgery an ophthalmic laser presented with display issues.Surgery was completed using alternate with no reports of patient impact.

Manufacturer Narrative

The company service representative examined the system and replicated the reported event.The company service representative found the flex cable to cause a flickering issue.The nonconforming flex cable was replaced to resolve the issue.The system was then tested and met all product specifications.The system manufacturing device history record (dhr) was reviewed.Based on qa assessment, the product met specifications at the time of release.The root cause of the reported event can be attributed to a nonconforming flex cable.Manufacturer will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).

• Brand Name: PUREPOINT LASER
• Type of Device: LASER, OPHTHALMIC
• MDR Report Key: 12222112
• MDR Text Key: 263367696
• Report Number: 2028159-2021-00799
• Device Sequence Number: 1
• Product Code: HQF
• UDI-Device Identifier: 00380657505975
• UDI-Public: 00380657505975
• Combination Product (y/n): N
• PMA/PMN Number: K062624
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 10/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065750597
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2009
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1