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
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 healthcare professional reported that during vitreoretinal surgery, an ophthalmic forceps tip unable to open.Procedure details and patient impact have not been provided.Additional information has been requested, none received till date.
Additional Manufacturer Narrative
Additional information has been provided in b.5 and h.6.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information received indicates that the surgery was completed by replacing the forceps.No patient impact was reported.
Additional Manufacturer Narrative
Additional information was provided in sections d.9, h.3 h.6 and h.11.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.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 completed based on the sample evaluation documented below.The returned instrument was received at the investigation site in its inner blister and covered with plastic bag.There was a piece of secondary packaging showing the lot information.The instrument was provided in a closed state and does not show macroscopic signs of damage.There are minor signs of surgery residues.The returned instrument was visually inspected with the aid of a photomicroscope using various magnifications and was functionally tested.It was found that the forceps could not be actuated, remains in a close state.The fact that the instrument stocks in a closed state indicates that the bonding between tube and sleeve got broken.As the blister was opened by the customer, the product was handled.Therefore, the point in time when the malfunction occurred can no longer be determined, nor can the strain put on the device be reconstructed.The customer¿s complaint is confirmed, but a root cause for the connection failure cannot be determined conclusively.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: 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: 20913895
• Report Number: 3003398873-2024-00139
• Device Sequence Number: 12911405
• Product Code: HNR
• UDI-Device Identifier: 07612717071544
• UDI-Public: (01)07612717071544(17)270430(11)240502(10)16RYR3
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/13/2025

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: 16RYR3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/13/2024
• Supplement Date Received by Manufacturer: 12/24/2024; 01/27/2025
• Initial Report FDA Received Date: 12/12/2024
• Supplement Report FDA Received Date: 01/17/2025; 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2024
• 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