MAUDE Adverse Event Report: ALCON GRIESHABER AG GRIESHABER ADVANCED DSP TIP SCISSORS; SCISSORS, OPHTHALMIC

Catalog Number	725.52
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported that, during vitrectomy surgery the tip of an ophthalmic scissors did not work.The surgery was completed with alternative scissors on the same day and 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 is provided in sections: d.9, h.3, h.6 & h.11.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 relevant deviation and that there are no additional complaints associated with it.The investigation is concluded based on the sample evaluation outlined below.The returned instrument was received in its inner and outer blister, covered by the tyvek lid foil showing the lot information.The instrument showed no macroscopic signs of damage and surgery residues.The scissors was returned in an open state.The scissors was visually inspected with the aid of a photomicroscope using various magnifications.The visual inspection revealed no immediate issues such as deformation of the scissor blades.The device was then functionally tested, and it was found that the actuation mechanism works as intended and the scissors closes and reopens properly upon actuating the instrument.The opening of the scissor blades was tested with the corresponding inspection equipment and was confirmed to be within specification.Therefore, the customer's complaint could not be confirmed.A root cause for the customer's 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: GRIESHABER ADVANCED DSP TIP SCISSORS
• Common Device Name: SCISSORS, 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: 21100228
• Report Number: 3003398873-2025-00006
• Device Sequence Number: 18336848
• Product Code: HNF
• UDI-Device Identifier: 07612717071063
• UDI-Public: (01)07612717071063(17)261130(11)231214(10)16DWFP
• 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): 03/06/2025

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: 725.52
• Device Lot Number: 16DWFP
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/27/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/11/2024
• Supplement Date Received by Manufacturer: 02/27/2025
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2023
• 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.
• Patient Sex: Unknown