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

Catalog Number	705.52P
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/24/2024
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 healthcare professional reported that during a vitrectomy surgery, the ophthalmic scissors became blocked and would not open.Details regarding the completion of the procedure and patient harm were not reported.
Additional Manufacturer Narrative
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.Nevertheless, the sample did not show macroscopic signs of damage other than a slightly bent metal tube.The sample exhibits no evident signs of surgery residues.The sample was visually inspected with the aid of a photomicroscope with various magnifications.The visual inspection showed no abnormalities such as deformation or other defects on the sample.The sample was then functionally tested and it was noticed that the forceps gets stuck in an actuated state, while the actuation mechanism itself is still in working condition.The forceps can only get opened again by manually pushing down the metal shaft, indicating that the bonding connection between the shaft and stiffening sleeve got broken.It was additionally noticed that the bonding between the plastic cap and the stiffening sleeve was broken as well.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.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 is no additional complaints associated with it.The investigation is completed based on the sample evaluation outlined below.No root cause for the customers reported event could be determined, since the situation that lead to the instrument failure cannot be reconstructed.The exact root cause for the customers 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: GRIESHABER REVOLUTION DSP SCISSORS
• Common Device Name: SCISSORS, 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: 19583537
• Report Number: 3003398873-2024-00063
• Device Sequence Number: 3433926
• Product Code: HNF
• UDI-Device Identifier: 07612717070691
• UDI-Public: (01)07612717070691(17)251231(11)230113(10)159ALK(21)NA
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2024

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: 12/31/2025
• Device Catalogue Number: 705.52P
• Device Lot Number: 159ALK
• 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: 06/10/2024
• Supplement Date Received by Manufacturer: 10/01/2024
• Initial Report FDA Received Date: 06/21/2024
• Supplement Report FDA Received Date: 10/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2023
• 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