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

Catalog Number	8065751114
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2024
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 physician reported that during a vitrectomy, an ophthalmic laser probe could not pass through the ophthalmic trocar.The surgery was successfully completed with an alternative product, and there was no impact on the patient.
Additional Manufacturer Narrative
Additional information is provided in sections d.4., d.9, h.3, h.6 and h.11.The product under investigation is not a serviceable device.Therefore, a service record review was not performed.However, a 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 non-conformance based review of the lot was performed and a potential contributing factor to the reported complaint was identified.Nonconformance investigation was opened but was later determined to not be relevant to this investigation.A review for complaints reported against this lot was performed.No similar complaints were reported for the product lot under investigation with a similar event code.The probe was received for testing on this investigation.The sample¿s radio frequency identification (rfid) tag was read, and the sample was found to not be associated with the customer¿s reported lot.The sample is unrelated to the customer¿s reported event.The sample is unrelated to the customer¿s reported event.Based on the information obtained, 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: 19970290
• Report Number: 9681121-2024-00041
• Device Sequence Number: 8801902
• Product Code: HQE
• UDI-Device Identifier: 00380657511143
• UDI-Public: (01)00380657511143(17)270228(11)240319(10)31571844
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2024

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 Catalogue Number: 8065751114
• Device Lot Number: 31571844
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/16/2024
• Supplement Date Received by Manufacturer: 10/03/2024
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2024
• 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