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

Catalog Number	705.52
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/15/2024
Type of Reportable Event	Serious Injury
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 physician reported that during vitrectomy surgery an ophthalmic scissor remained open position and could not remove it through trocar or cannula where the entry point was enlarged and the scissors were removed from the patient eye post which sutures were used to close the wound.It was clear that the patient had no impact and was recovered with no residual effects and also the sutures were removed.
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 is no additional complaints associated with it.The investigation is completed based on the sample evaluation outlined below.The returned instrument was received in its outer blister and with the cover foil.The inner blister, which offers protection to the instrument during shipment, was not used.The scissors blades of the instrument are severely bent.This is probably because of transport damage.The returned instrument was visually inspected with the aid of a photomicroscope under various magnifications.As the blister was opened by the customer, the product was handled and used on a patient.The situation in which the malfunction occurred can no longer be determined, nor can the strain put on the device be reconstructed.Even though the damage that is evident on the returned instrument does not align well with the complainant¿s report, this investigation confirms that the product is defective.However, the root cause could not be identified.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: 20210205
• Report Number: 3003398873-2024-00102
• Device Sequence Number: 20706353
• Product Code: HNF
• UDI-Device Identifier: 07612717064638
• UDI-Public: (01)07612717064638(17)250731(11)220802(10)14XYLR(21)NA
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2025
• Device Catalogue Number: 705.52
• Device Lot Number: 14XYLR
• 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: 08/15/2024
• Supplement Date Received by Manufacturer: 12/19/2024
• Initial Report FDA Received Date: 09/13/2024
• Supplement Report FDA Received Date: 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 31 YR
• Patient Sex: Female