MAUDE Adverse Event Report: WAVELIGHT GMBH WAVELIGHT FS200 EASYPACK PATIENT INTERFACE; POWERED LASER SURGICAL INSTRUMENT

Model Number 1515

Device Problem Suction Problem (2170)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/14/2023

Event Type  malfunction  

Manufacturer Narrative

H.3., h.6.: 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 suction broke during creation of the flap at forty eight percent (after laser fired) in the left eye of a patient, during lasik surgery.There are multiple related reports for this facility.This report addresses a sn (b)(6) and additional manufacturer reports will be filed.

Manufacturer Narrative

A review of the device history record (dhr) traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.The review of logfile for the day of treatment shows all laser system functions were within specifications.The vacuum check, the energy check and the ablation check were performed successfully without issues.The energy was stable during this period.The logfile shows forty-one successfully performed treatments.The reported treatment could be identified in the logfile.The log file shows that the beam control check was performed about one minute and thirty-two seconds before the start of the treatment and not immediately before the treatment.The surgeon interrupted the treatment twice by releasing the laser pedal during treatment.The treatment of the patient's left eye was aborted due to the user released the laser pedal and pressed the vacuum pedal instead of the laser pedal, which caused the interruption of the treatment during bed cut.The reported issue is not caused by the system or the used patient interface.The info message ¿vacuum pumps stopped by foot pedal - treatment is aborted¿ indicated that the user shut down the vacuum pumps by pressing the vacuum pedal instead of the laser pedal.The user restarted the treatment on the same day with a new patient interface and finished the treatment without any problems.Review of the logfiles for the treatment day shows no relevant warning or error messages.No technical root cause was identified as the product was found to be within specifications.The root cause is user handling.The treatment was stopped by pressing food pedal and could be finished successfully using another patient interface.The manufacturer internal reference number is: (b)(4).

• Brand Name: WAVELIGHT FS200 EASYPACK PATIENT INTERFACE
• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): WAVELIGHT GMBH; am wolfsmantel 5; erlangen 91058 ; GM 91058
• Manufacturer (Section G): WAVELIGHT GMBH; am wolfsmantel 5; erlangen 91058 ; GM 91058
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 17057464
• MDR Text Key: 316497854
• Report Number: 3003288808-2023-00157
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 00000000000000
• UDI-Public: 00000000000000
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190392
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1515
• Device Catalogue Number: 8065998299
• Device Lot Number: 14U34T
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 28 YR
• Patient Sex: Female