MAUDE Adverse Event Report: ALCON GRIESHABER AG FINESSE REFLEX DSP FORCEPS; FORCEPS, OPHTHALMIC

Catalog Number	811.13
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported that during vitrectomy surgery, an ophthalmic forceps tip unable to open and close.The procedure was completed using new device.There's 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
A review of the device history record (dhr) traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.A review of the database for the non-conformance events and the complaints showed that the given lot number was not concerned by any deviation and that there is one additional complaint with the same event code associated with it but the production lot did not exceed the minimum threshold for one month.The investigation is concluded based on the sample evaluation outlined below.The sample was received in its inner and outer blister and with the cover foil showing the lot information.It exhibited no macroscopic signs of damage and the forceps was returned in an open state.The sample shows some surgery residues.The sample was visually inspected with the aid of a photomicroscope using various magnifications.The visual inspection revealed no immediate issues such as deformation of the forceps arms.The device was then functionally tested, and it was found that the actuation mechanism works as intended and the forceps closes and reopens properly upon actuating the instrument.Finally, the device was subjected to a grasping force test that showed that the sample was able to grasp and hold the corresponding internal control weight (pm80.224/05), which indicates that the product fulfills its requirements regarding the grasping force.Therefore, the customers complaint could not be confirmed.A root cause for the customers reported event could not be determined because the returned product met manufacturer¿s specifications.No action was taken as the returned sample met specifications for tests performed in relation to the reported event.Complaints are reviewed and monitored at regular intervals for adverse trends.No adverse trends have been observed associated with the reported product and event.No action has been identified for this reported event.The manufacturer internal reference number is: (b)(4).

• Brand Name: FINESSE REFLEX DSP FORCEPS
• Common Device Name: FORCEPS, OPHTHALMIC
• Manufacturer (Section D): ALCON GRIESHABER AG; winkelriedstrasse 52; schaffhausen 8203 ; SZ 8203
• Manufacturer (Section G): ALCON GRIESHABER AG; winkelriedstrasse 52; schaffhausen 8203 ; SZ 8203
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 19021251
• Report Number: 3003398873-2024-00032
• Device Sequence Number: 3772729
• Product Code: HNR
• UDI-Device Identifier: 07612717071575
• UDI-Public: 07612717071575
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• 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): 05/27/2024

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: 811.13
• Device Lot Number: 147EU9
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/21/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/06/2024
• Supplement Date Received by Manufacturer: 05/01/2024
• Initial Report FDA Received Date: 04/02/2024
• Supplement Report FDA Received Date: 05/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2022
• 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
• Patient Sex: Unknown