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 Codes	Break (1069); Device Handling Problem (3265)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/30/2024
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 customer reported that during vitrectomy surgery, an ophthalmic forceps tip fell into the patient's eye and could not be retrieved.A secondary procedure was conducted to retrieve the device from the patient's eye.It was further reported that the device had already expired before the event.The current status of the patient is unknown.
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.A design change was already initiated and implemented to improve the reliability of the concerned connection on the device.As stated in the attached material, the device was expired by two months at the time it was used.The investigation is concluded based on the sample evaluation outlined below.The sample was received at the investigation site stuck with tape to the product¿s outer blister covered.The inner blister offering protection during the shipment was not used.The sample shows macroscopic signs of damage, namely that the silicone soft tip is broken off and that the metal tube is slightly bent.There are no signs of surgery residues on the device.The sample was visually inspected with the aid of a photomicroscope using various magnifications.The visual inspection confirms that the silicone soft tip was sheared off at the connection site to the metal tube.This confirms the customer¿s complaint.A soft tip that is sheared off is typically caused by user handling.The soft tip needs to be inserted axially aligned with the valve trocar 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 this specific damage 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).
Additional Manufacturer Narrative
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: 19617416
• Report Number: 3003398873-2024-00065
• Device Sequence Number: 12536923
• Product Code: HQE
• UDI-Device Identifier: 07612717071414
• UDI-Public: (01)07612717071414(17)240331(11)210427(10)13VM74(21)NA
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K884043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/25/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: 337.88
• Device Lot Number: 13VM74
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/29/2024
• Supplement Date Received by Manufacturer: 08/29/2024; 09/27/2024
• Initial Report FDA Received Date: 06/26/2024
• Supplement Report FDA Received Date: 09/27/2024; 10/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2021
• 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 Sex: Female