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	Particulates (1451)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/11/2023
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 a combined cataract and vitrectomy for retinal detachment procedure an ophthalmic backflush tip came loose during the fluid/air exchange (fax) mode and remained in the eye.The surgery was completed and patient impact was not reported.Additional information has been requested but none received till date.
Additional Manufacturer Narrative
The investigation is completed.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 design change was initiated to improve the reliability of the device.The sample was received with inner blister and without outer blister or cover foil.The sample was visually inspected with the aid of a photomicroscope with various magnifications.The soft tip is broken and no residuals are visible.It was noticed during visual inspection that the tube was cutting off.The customer¿s complaint was confirmed.The soft tip has 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.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.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: 16213433
• Report Number: 3003398873-2023-00012
• Device Sequence Number: 4392233
• Product Code: HQE
• UDI-Device Identifier: 07612717071414
• UDI-Public: 07612717071414
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2023

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: 03/31/2024
• Device Catalogue Number: 337.88
• Device Lot Number: 13VM01
• 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: 01/12/2023
• Supplement Date Received by Manufacturer: 03/23/2023
• Initial Report FDA Received Date: 01/20/2023
• Supplement Report FDA Received Date: 04/19/2023
• 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
• Patient Sex: Unknown