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

Catalog Number 337.88

Device Problem Break (1069)

Patient Problems Hematoma (1884); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/19/2022

Event Type  Injury  

Event Description

A physician reported that an ophthalmic backflush came off in the patient's eye during retinal detachment surgery.The patient underwent to a medical intervention to remove the broken tip.Additional information has been requested none received till date.

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 Description

Additional information received from the physician indicating when picking up back flush.Tip came off while aspirating sub retinal fluid.It dropped into retinal tear hemorrhaged when picked up it with forceps.Hemorrhaged from the rupture on the lateral side of the eye, flowed into the sub retina and precipitated as a hematoma in the posterior pole of the eye.

Manufacturer Narrative

Additional information is provided in section a.2, a.3, b.3., b.5., b.7., e.1.And h.6.The manufacturer internal reference number is: (b)(4).

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.Sample was not received by the investigation site for evaluation.The root cause cannot be identified conclusively because no picture or sample has been received.Investigation has been completed based on current information.Should sample returned, this file will be re-opened, and failure analysis will be performed.The manufacturer internal reference number is: (b)(4).

• Brand Name: BACKFLUSH HANDLE DSP
• Type of Device: 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: 14433139
• MDR Text Key: 292027824
• Report Number: 3003398873-2022-00033
• Device Sequence Number: 1
• Product Code: HQE
• UDI-Device Identifier: 07612717071414
• UDI-Public: 07612717071414
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K884043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: 337.88
• Device Lot Number: F208945
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male