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

Catalog Number	8065750978
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A sample is available that has not yet been received at manufacturing for evaluation.No lot number information has been received by manufacturing.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 physician reported that during a combination cataract and vitrectomy surgery, an ophthalmic laser probe could not be inserted into the trocar.An alternate laser probe was obtained in order to complete the surgery.There was no patient harm.
Additional Manufacturer Narrative
No further information was able to be obtained from this customer.The customer returned their laser probe for evaluation.The laser probe was received for evaluation.A visual assessment of the returned sample showed no obvious non-conformities.Further evaluation found the sample met specifications.The sample was found to meet specifications.Therefore, the root cause of the reported event cannot be determined conclusively.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: 12021033
• Report Number: 2028159-2021-00654
• Device Sequence Number: 11589230
• Product Code: HQE
• UDI-Device Identifier: 00380657509782
• UDI-Public: 00380657509782
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K946135
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2021

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 Catalogue Number: 8065750978
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2021
• Initial Date Received by Manufacturer: 05/25/2021
• Supplement Date Received by Manufacturer: 10/07/2021
• Initial Report FDA Received Date: 06/17/2021
• Supplement Report FDA Received Date: 11/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CONSTELLATION VISION SYSTEM.