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

Catalog Number	723.52
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2024
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 pars plana vitrectomy procedure in the left eye, an ophthalmic scissors tip broke off and fell into the eye.Piece of metal was removed.Surgery was completed with no patient harm.
Additional Manufacturer Narrative
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 sample only consisted of the metal tube with the scissor insert still embedded in it.The handle was not part of the delivery.The sample was provided in a little plastic container.None of the original packaging material was used for the shipment.The sample evidently shows macroscopic signs of damage.Apart from being broken away from the handle, it can be seen that one of the scissor blades was missing.The missing blade was not provided.There was no signs of surgery residues.The sample was visually inspected with the aid of a photomicroscope under various magnifications.The fractured surface was assessed and does not show any abnormalities that would indicate a root cause for the breakage.As the blister was opened by the customer and per the initial report description, 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.The customer¿s complaint is therefore confirmed but the root cause cannot be conclusively identified by this investigation.It cannot be determined how or where the damage to the sample occurred.Therefore, a root cause for the customer's reported event could not be determined conclusively.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: GRIESHABER ADVANCED DSP TIP 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: 19200096
• Report Number: 3003398873-2024-00044
• Device Sequence Number: 20815151
• Product Code: HNF
• UDI-Device Identifier: 07612717070950
• UDI-Public: (01)07612717070950(17)260131(11)230216(10)15CNJK(21)NA
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 08/23/2024

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: 01/31/2026
• Device Catalogue Number: 723.52
• Device Lot Number: 15CNJK
• 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: 04/17/2024
• Supplement Date Received by Manufacturer: 07/26/2024
• Initial Report FDA Received Date: 04/29/2024
• Supplement Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2023
• 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 Age: 51 YR
• Patient Sex: Female