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

Catalog Number	337.86
Medical Device Problem Code	Suction Failure (4039)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/11/2024
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 physician reported that during vitrectomy surgery in active pipetting process, an ophthalmic backflush did not pipette.Surgery was completed with an alternative backflush and with no report of 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.The sample was received with the outer blister and cover foil intact, but without the inner blister.Macroscopic inspection revealed signs of damage, including a broken soft-tip.There were no visible signs of surgical residue.The sample underwent visual inspection using a photomicroscope at various magnifications.Functional testing of the aspiration was conducted using an injector, revealing that the device is clogged.As the blister had been opened by the customer, the product was handled by them.The exact time of the malfunction cannot be determined.The customer's complaint is confirmed.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.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).
Event or Problem Description
Additional information received, indicated that event occurred before surgery.

• 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: 19059753
• Report Number: 3003398873-2024-00034
• Device Sequence Number: 6602972
• Product Code: HQE
• UDI-Device Identifier: 07612717071216
• UDI-Public: 07612717071216
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2024

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: 337.86
• Device Lot Number: 15K54U
• 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: 03/12/2024
• Supplement Date Received by Manufacturer: 06/06/2024
• Initial Report FDA Received Date: 04/08/2024
• Supplement Report FDA Received Date: 07/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2023
• 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