MAUDE Adverse Event Report: ALCON GRIESHABER AG FINESSE FLEX LOOP DSP; SPATULA, OPHTHALMIC

Catalog Number	338.25P
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported that ophthalmic operating scraper came out during insertion.The surgery was performed and completed after replacing the product with another one.The procedure type is unknown.The patient identifier are not available.There was no patient harm.
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).
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.The investigation is completed based on the sample evaluation documented below.The sample was received by the investigation site in its inner blister, outer blister and cover foil which shows the lot information.The sample shows macroscopic signs of damage: it is immediately evident that the tube was completely pulled out of the sleeve and provided separately.The separated tube is slightly bent.This confirms the reported event.The sample shows no signs of surgery residues.The sample was visually inspected with the aid of a photomicroscope under various magnifications.The visual inspection of the bonding site between tube and sleeve does not show any abnormalities from which a root cause of the breaking could be determined.As the blister was opened by the customer, the product was handled.It is therefore not possible the point in time when the malfunction occurred, can no longer be determined.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.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 conclusively.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: FINESSE FLEX LOOP DSP
• Common Device Name: SPATULA, 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: 18310993
• Report Number: 3003398873-2023-00220
• Device Sequence Number: 12300168
• Product Code: HND
• UDI-Device Identifier: 07612717071445
• UDI-Public: 07612717071445
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2024

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: 03/31/2026
• Device Catalogue Number: 338.25P
• Device Lot Number: 15JN42
• 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: 11/19/2023
• Supplement Date Received by Manufacturer: 01/31/2024
• Initial Report FDA Received Date: 12/12/2023
• Supplement Report FDA Received Date: 02/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/20/2023
• 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