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

Catalog Number	705.88P
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2024
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 nurse reported that during vitrectomy surgery, an ophthalmic forceps did not work and tip did not open.The forceps remained in the closed position.The surgery was completed on the same day by replacing the product with another one.No patient impact was reported.
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 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 investigation is concluded based on the sample evaluation outlined below.The returned instrument was received in its outer blister covered by the tyvek foil lid showing the lot information.The product shows macroscopic sign of damage, namely the forceps arms are significant bent.The instrument was visually inspected with the aid of a photomicroscope using various magnifications.The product shows signs of surgery residues.The visual inspection confirmed the macroscopically noticeable damage and displayed the deformation of the forceps arms in detail.The damage of the device, as well as the missing inner blister suggest that damage of the forceps arms on the product was caused during the shipping process from the complainant to the investigation site.The instrument was tested to determine whether the adhesive connection between the tube and sleeve was broken, which was confirmed.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.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: 21313305
• Report Number: 3003398873-2025-00174
• Device Sequence Number: 20870779
• Product Code: HNR
• UDI-Device Identifier: 07612717071544
• UDI-Public: (01)07612717071544(17)270831(11)240913(10)172759
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2025

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: 172759
• 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: 01/29/2025
• Supplement Date Received by Manufacturer: 03/11/2025
• Initial Report FDA Received Date: 02/05/2025
• Supplement Report FDA Received Date: 04/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2024
• 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