MAUDE Adverse Event Report: PT. CIBA VISION BATAM LASER PROBES; INSTRUMENT, VITREOUS ASPIRATION AND CUTTING, AC-POWERED

Catalog Number	8065751709
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2024
Type of Reportable Event	Malfunction
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).
Event or Problem Description
A clinical nurse reported that an ophthalmic laser probe was used during the combination of cataract and vitrectomy surgery and probe would not be able to insert into the cannula.The surgery was completed with alternative probe.There was no report of patient harm.
Additional Manufacturer Narrative
Additional information provided in sections d.9.H.3.H.6 and h.10.The product under investigation is not a serviceable device.Therefore, a service record review was not performed.However, there was a laser probe returned for testing on this investigation.A non-conformance based review of the lot 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 number was performed.A quality summary (qs) was opened to address a product insertion issue into the port.Root cause was attributed to foreign material found in the probe cannula during a sample evaluation.However, it remains inconclusive how or when the unknown foreign material was deposited on the cannula.The laser probe was received for testing.Initially the sample was incorrectly identified to not be associated with the customer reported event after the rfid tag lot was read.However, after further identification, the radio frequency identification (rfid) tag lot was determined to be matching to the customer report.The returned sample was connected to a calibrated system and was successfully recognized.A visual assessment under a microscope was performed and revealed clear foreign material adhered to the probe cannula.A fit check was performed with a trocar and had difficulty passing through.Foreign material was deposited on the cannula.However, it remains inconclusive how or when the foreign material was deposited on the probe cannula.Therefore, the root cause of the reported event is 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: 18701881
• Report Number: 9681121-2024-00011
• Device Sequence Number: 12298073
• Product Code: HQE
• UDI-Device Identifier: 00380657517091
• UDI-Public: 00380657517091
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K946135
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2024

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: 12/31/2024
• Device Catalogue Number: 8065751709
• Device Lot Number: 31530583
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/22/2024
• Supplement Date Received by Manufacturer: 04/18/2024
• Initial Report FDA Received Date: 02/14/2024
• Supplement Report FDA Received Date: 05/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2023
• 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