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

Catalog Number	705.44
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2025
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 customer reported that an ophthalmic forceps was failed to open.The surgery was completed with alternative forceps.There was no patient harm.Procedure details have not been provided.Additional information has been requested, none has been received till date.
Additional Manufacturer Narrative
Additional information is provided in sections d.9, h.3, h.6 and h.11.A review of the device history record (dhr) traceable to the reported lot numbers, indicates that the reported product was processed and released according to the reported 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 are no additional complaints associated with it.The investigation is completed based on the sample evaluation documented below.The returned instrument was received in its outer blister covered by the tyvek foil, shows the lot information.The inner blister which offers protection to the instrument during shipment, was not used.The product shows macroscopic sign of damage, especially the metal tube and the forceps arms are significant deformed.The instrument was visually inspected with the aid of a photomicroscope with various magnification.The visual inspection confirms the deformed forceps arms in detail.Since the instrument was insufficient protected during the shipment from the complainant to the investigation site and the forceps deformation is not described in the initial report, it is assumed that this deformation occurred during the shipment.As the blister was opened by the costumer, the product was handled.Therefore, the point in time when the deformation occurred can no longer be determined, nor can the strain put on the device be reconstructed.The costumer's complaint is confirmed, but a root cause for the deformation cannot be determined.It cannot be determined how or where the damage to the sample occurred.Therefore, the root cause for the customer's reported event could not be determined.The exact root cause for the customer's reported event is unknown, therefore, specific action cannot be taken.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 REVOLUTION 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: 21303602
• Report Number: 3003398873-2025-00168
• Device Sequence Number: 8020173
• Product Code: HNR
• UDI-Device Identifier: 07612717064263
• UDI-Public: (01)07612717064263(17)270531(11)240613(10)16W17M
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2025

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: 705.44
• Device Lot Number: 16W17M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/16/2025
• Supplement Date Received by Manufacturer: 03/14/2025
• Initial Report FDA Received Date: 02/04/2025
• Supplement Report FDA Received Date: 04/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2024
• 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