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

Catalog Number	725.44P
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2024
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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Event or Problem Description
A nurse reported that two ophthalmic surgical forceps could not be opened after being closed during vitrectomy surgery.The surgery was completed on the same day.No patient impact was reported.
Additional Manufacturer Narrative
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 deviation and that there are no additional complaint associated with it.The investigation is completed based on the sample evaluation documented below.The sample was received in its outer blister, covered with the tyvek lid foil showing the lot information.The inner blister, which offers protection to the instrument during shipment, was not used.The sample shows no macroscopic signs of damage but it is evident that the forceps is in a closed state when the handle is not actuated, with the grasping arms being pulled far into the metal shaft.The sample exhibits some signs of surgery residues.The sample was visually inspected with the aid of a photomicroscope using various magnifications and was functionally tested.During the inspection, it was confirmed that the forceps gets stuck in a closed state and can only get opened again by manually pushing down the metal shaft, indicating the bonding connection between the shaft and the sleeve got broken.This confirms the customer¿s complaint.As the blister was opened by the customer, the product was handled.However, it is not possible to determine what situation could have caused the malfunction and no root cause can be identified conclusively.No root cause for the customer's reported event could be determined, since the situation that lead to the instrument failure cannot be reconstructed.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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.

• Brand Name: GRIESHABER ADVANCED DSP TIP 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: 19744299
• Report Number: 3003398873-2024-00077
• Device Sequence Number: 14344791
• Product Code: HNR
• UDI-Device Identifier: 07612717071018
• UDI-Public: 07612717071018
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 09/22/2024

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 Expiration Date: 07/31/2026
• Device Catalogue Number: 725.44P
• Device Lot Number: 164JAE
• 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: 06/20/2024
• Supplement Date Received by Manufacturer: 08/30/2024
• Initial Report FDA Received Date: 07/15/2024
• Supplement Report FDA Received Date: 09/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2023
• 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