MAUDE Adverse Event Report: ALCON GRIESHABER AG BACKFLUSH HANDLE DSP; INSTRUMENT, VITREOUS ASPIRATION AND CUTTING, AC-POWERED, ACCESSORY

Catalog Number	337.88
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/25/2024
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 customer reported that the head of the ophthalmic handle crooked during surgery.The surgery was completed after replacing the product with another one.The details of patient impact was not reported.
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 other complaints associated with it.The investigation is concluded based on the sample evaluation outlined below.The sample was received in its inner and outer blister and the cover foil, which shows the lot information.The sample shows macroscopic signs of damage, specifically, it can be seen that the soft tip is missing completely.The sample was visually inspected with the aid of a photomicroscope using various magnifications.The visual inspection confirms that the polyurethane soft tip was missing completely and that there is a minor level of deformation on the front end of the metal tube.This confirms the customer¿s complaint.A soft tip that is completely missing is typically removed voluntarily or caused by user handling.The soft tip needs to be inserted axially aligned with the valve trocar cannula and then moved slightly back before it is completely inserted into the trocar cannula.Otherwise kinking of the soft tip may occur, provoking a potential shearing-off of the soft tip.However, the root cause of the damage seen on this returned sample cannot be identified conclusively.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.However, the damage was consistent with damage that can occur due to improper handling.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: BACKFLUSH HANDLE DSP
• Common Device Name: INSTRUMENT, VITREOUS ASPIRATION AND CUTTING, AC-POWERED, ACCESSORY
• 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: 19201269
• Report Number: 3003398873-2024-00045
• Device Sequence Number: 20859849
• Product Code: HQE
• UDI-Device Identifier: 07612717071414
• UDI-Public: 07612717071414
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K884043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2024

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: 02/28/2026
• Device Catalogue Number: 337.88
• Device Lot Number: 15ER4A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/03/2024
• Supplement Date Received by Manufacturer: 06/01/2024
• Initial Report FDA Received Date: 04/29/2024
• Supplement Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2023
• 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