MAUDE Adverse Event Report: PT. CIBA VISION BATAM 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	04/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare professional reported that during a combination of a cataract and vitrectomy surgery an ophthalmic laser probe would not go completely into the trocar.Procedure was completed using another product.There was no patient harm.
Additional 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).
Additional Manufacturer Narrative
Additional information was provided in sections d.9, h.3, h.6 and h.10 the 23 gauge ophthalmic laser probe was received, and a visual assessment of the returned sample revealed a non-conforming tip.The returned laser probe sample was then inserted into a trocar where it was found to have resistance.The laser probe was observed under a microscope the sample to have excessive adhesive adhered at the nitinol-cannula junction, confirming the customer¿s reported event.Unrelated to the reported event, the sample was returned with a missing nitinol tip.However, how, or when this nonconformity occurred remains inconclusive.It should be noted that the laser probes are visually inspected during manufacturing to verify the tips are conforming.A laser probe non-conformance based review of the batch/lot/serial number was performed and did not reveal any potential contributing factors to the reported complaint.A manufacturing device history record (dhr) review was performed prior to product release to ensure that the product was manufactured in compliance with the device master record.Based on the assessment, the product met release criteria.A review for complaints reported against this lot/batch/serial number was performed.No similar complaints were reported for the product lot/batch/serial under investigation.The product under investigation is not a serviceable device.Therefore, a service record review was not performed.The root cause of the reported event is attributed to excess adhesive on the nitinol-cannula junction.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).
Additional Manufacturer Narrative
Additional information was provided in sections h.6 and h.10.The product under investigation is not a serviceable device.Therefore, a service record review was not performed.However, the probe was returned for testing on this investigation.A non-conformance based review of the serial number was performed and did not reveal any potential contributing factors to the reported complaint.A manufacturing device history record (dhr) review was performed prior to product release to ensure that the product was manufactured in compliance with the device master record.Based on the assessment, the product met release criteria.A review for complaints reported against this serial number was performed.No similar complaints were reported for the product serial under investigation.The probe was received for testing on this investigation.A visual assessment of the returned sample revealed a non-conforming tip, which had a missing nitinol.The returned sample was connected to a calibrated system and was successfully recognized.The sample was then inserted into a 23g trocar where it was found to have resistance.A visual assessment under a microscope was performed and identified a clear foreign material was present on the cannula.The root cause of the reported event is attributed to a clear foreign material being present on the cannula.However, how or when the foreign material was introduced onto the cannula remains inconclusive.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
• Manufacturer (Section D): PT. CIBA VISION BATAM; beringin kav. #204 batamindo; industrial park muka kuning; pulau batam 29433 ; ID 29433
• Manufacturer (Section G): PT. CIBA VISION BATAM; beringin kav. #204 batamindo; industrial park muka kuning; pulau batam 29433 ; ID 29433
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 14939323
• Report Number: 9681121-2022-00006
• Device Sequence Number: 17699938
• Product Code: HQE
• UDI-Device Identifier: 00380657511136
• UDI-Public: 00380657511136
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K946135
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/03/2023

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: 06/30/2024
• Device Catalogue Number: 8065751113
• Device Lot Number: 31463432
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/29/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/16/2022
• Supplement Date Received by Manufacturer: 09/13/2022; 07/13/2023
• Initial Report FDA Received Date: 07/06/2022
• Supplement Report FDA Received Date: 10/07/2022; 08/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown