MAUDE Adverse Event Report: ALCON GRIESHABER AG FINESSE SHARKSKIN ILM FORCEPS; FORCEPS, OPHTHALMIC

Catalog Number	705.88P
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported that the jaw of an ophthalmic forceps would not open.It was noted that vitreoretinal surgery was scheduled, 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 and h.11.A review of the device history record 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 are no additional complaints associated with it.The returned instrument was received at the investigation site in its outer blister and with the cover foil showing the lot information.The inner blister, which ensure 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 and the shaft are deformed significantly.The product 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.The extent of the damage as well as the missing blisters suggest that the deformation of the forceps arms and the shaft 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.It cannot be determined how or where the damage to the sample occurred; therefore a root cause for the customers 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: FINESSE SHARKSKIN ILM 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: 20639684
• Report Number: 3003398873-2024-00127
• Device Sequence Number: 7463898
• Product Code: HNR
• UDI-Device Identifier: 07612717071544
• UDI-Public: (01)07612717071544(17)270430(11)240503(10)16T2FL
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 01/29/2025

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: 705.88P
• Device Lot Number: 16T2FL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/14/2024
• Supplement Date Received by Manufacturer: 01/13/2025
• Initial Report FDA Received Date: 11/08/2024
• Supplement Report FDA Received Date: 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2024
• 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