MAUDE Adverse Event Report: LASER PROBES; INSTRUMENT, VITREOUS ASPIRATION AND CUTTING, AC-POWERED

Catalog Number	8065751113
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample has been received and in-house evaluation is in progress.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 or Problem Description
A customer reported that during surgery the laser probe would not go through trocar.There was a patient contact but there was no patient impact noted.The procedure was completed by using new laser probe.There was no medical or surgical intervention required as result of the event.
Additional Manufacturer Narrative
Probe was received for evaluation.A visual assessment of the returned sample showed no obvious non-conformities.However, the trocar was stuck on the laser probe.The root cause can be attributed to excess adhesive on the nitinol-cannula junction.There were 930 paks associated with this lot.Based on qa assessment, the product met specifications at the time of release.The root cause can be attributed to excess adhesive on the nitinol-cannula junction.The 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: LASER PROBES
• Common Device Name: INSTRUMENT, VITREOUS ASPIRATION AND CUTTING, AC-POWERED
• MDR Report Key: 11907230
• Report Number: 2028159-2021-00561
• Device Sequence Number: 16396342
• Product Code: HQE
• UDI-Device Identifier: 00380657511136
• UDI-Public: 00380657511136
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K946135
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: 8065751113
• Device Lot Number: 13MP3W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2021
• Initial Date Received by Manufacturer: 05/07/2021
• Supplement Date Received by Manufacturer: 09/01/2021
• Initial Report FDA Received Date: 05/31/2021
• Supplement Report FDA Received Date: 09/27/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1