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

Catalog Number	705.44P
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/28/2025
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 during vitrectomy surgery, an ophthalmic forceps would not open and close completely.The surgery was completed with alternative product.No impact on patient was reported.
Additional Manufacturer Narrative
Additional information is provided in sections d.4, d.9, h.3, h.6 and h.11.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 no additional complaints associated with it.The investigation is completed based on the sample evaluation outlined below.The returned instrument was received in its outer blister, covered with the tyvek foil lid shoeing the lot information.The inner blister, which ensures that the product is kept safe from damage during the shipment, was not used.The product shows obvious macroscopic signs of damage.Specifically, the forceps arms are deformed significantly.There are a few signs of surgery residues.The instrument was visually inspected with the aid of a photomicroscope using various magnifications.The visual inspection confirmed the macroscopically noticeable damage and displayed the deformation of the forceps arms in detail.Due to the extensive damage, the opening and closing of the device could not be tested, nor could any other functional tests be performed.The damage of the device which does not correspond to the initial report description very well, as well as the missing inner blister suggest that the deformation of the forceps arms was caused during the shipping process from the complainant to the investigation site.However, the point in time when the noticed malfunction occurred can no longer be determined conclusively, nor can the strain put on the device be reconstructed.The customer¿s complaint is confirmed as the returned device shows significant deformation, but a root cause for the reported issue cannot be determined.A review of the device history record traceable to the reported lot numbers, indicates that the reported product was processed and released according to the reported product¿s acceptance criteria.Non-conformance report provided by originator.A non-conformance based review of the lot number was performed and did not reveal any potential contributing factors to the reported complaint.It cannot be determined how or where the damage to the sample occurred; therefore a root cause for the customer's reported event could not be determined.As the root cause and its origin are inconclusive, further investigative or manufacturing actions are not warranted at this time.Receipt of additional relevant information or supporting materials will prompt a re-evaluation of the complaint investigation.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: 22026093
• Report Number: 3003398873-2025-00285
• Device Sequence Number: 9390761
• Product Code: HNR
• UDI-Device Identifier: 07612717070622
• UDI-Public: (01)07612717070622(17)271130(11)241212(10)176DYD
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2025

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: 705.44P
• Device Lot Number: 176DYD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/05/2025
• Supplement Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2024
• 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