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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/18/2021

Event Type  malfunction  

Manufacturer Narrative

A sample is available that has not yet been received at manufacturing for evaluation.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 physician reported that the soft tip of an ophthalmic backflush device came off into the patient's eye during a vitrectomy surgery.The detached tip could not be confirmed to have been removed from the eye.An alternate backflush device was obtained in order to complete the procedure.There was with no harm to the patient.

Manufacturer Narrative

One backflush sample was received in an inner and outer blister without the cover foil.A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.The received sample was visually inspected with the aid of a photomicroscope with various magnifications.The soft tip is broken.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.The most probable root cause is user handling with regards to the insertion technique of the device into the trocar cannula.A graphical description on how to properly insert the soft tip device through the valved trocar cannula was implemented in the directions for use (dfu) in (b)(6) 2015.As the current dfu contains the graphical description on how to properly insert the soft tip, no further actions are necessary.This report has been reviewed and future data will be monitored for evidence of adverse trending with further action taken, as appropriate.At a minimum, this will include completing reviews of complaint class report levels on a monthly basis.The manufacturer internal reference number is: (b)(4).

Event Description

Additional information received further clarified that it is not confirmed where the detached soft tip is located.Postoperative optical coherence tomography (oct) performed on the patient's left eye did not show any suspected signs.During another, subsequent surgery for retinal detachment that occurred postoperatively, again no detached tip was confirmed around the center part of the retina that would affect visual acuity.The patient's condition is currently stated as improving.

• 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: 11614430
• MDR Text Key: 243784412
• Report Number: 3003398873-2021-00025
• Device Sequence Number: 1
• Product Code: HQE
• UDI-Device Identifier: 07612717071414
• UDI-Public: 07612717071414
• 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: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: 337.88
• Device Lot Number: F189063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2021
• Date Manufacturer Received: 04/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 41 YR