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

Catalog Number 337.88

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/21/2019

Event Type  malfunction  

Manufacturer Narrative

No sample has been received by manufacturing for evaluation.The device history record for the affected lot was reviewed.No abnormalities that could have contributed to this event were found in the production documentation and the sample was released according to acceptance criteria.A 100% final inspection is performed for this product.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

A nurse reported that the soft tip of an ophthalmic backflush device detached into a patient's eye during vitrectomy surgery.The detached tip remains inside of the patient's eye.Patient impact information is unknown.Additional information has been requested.Additional information received further clarified that the surgeon attempted to pick up the detached tip during the same surgery, but the tip could not be removed from the eye.No further patient information is available.

Manufacturer Narrative

The received sample was found in the outer blister of a backflush and in a different outer blister.The cover foil was included and the sample was protected with bubble wrap, but not well fixed.The sample is very bent.The detached soft tip is not available.The sample was visually inspected with the aid of a photomicroscope with various magnifications.The customer¿s complaint was confirmed.The soft tip is broken, but the sample is also very bent.The soft tip has to be inserted axially aligned with the valved 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.A malfunction of the device could not be determined, but bending of the instrument indicates to an external force.The most probable root cause is the insertion technique of the soft tip device into the valved trocar cannula.A graphical description on how to properly insert the soft tip through the valved trocar cannula was implemented in the product directions for use (dfu) in july 2015.As the current dfu contains the graphical description on how to properly insert the soft tip, no further actions are necessary.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
• MDR Report Key: 8957608
• MDR Text Key: 156723228
• Report Number: 3003398873-2019-00067
• Device Sequence Number: 1
• Product Code: HQE
• Combination Product (y/n): N
• PMA/PMN Number: K884043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 11/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: 337.88
• Device Lot Number: F148206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2019
• Date Manufacturer Received: 11/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1