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

Catalog Number 337.88

Device Problems Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/06/2018

Event Type  Injury  

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.Additional information has been requested.(b)(4).

Event Description

A doctor reported that the soft tip of an ophthalmic backflush device tore off into a patient's right eye during vitrectomy surgery and was retained inside of the eye.The detached tip is planned to be removed from the eye when instilled silicone oil is subsequently removed from the eye at a later date.There is no impact to the patient.Additional information received further clarified that while the detached soft tip was not removed from the eye, it is also not confirmed to be have been retained inside of the eye.It was further clarified that there was never any silicone oil instilled into the eye rather, ophthalmic gas was instilled instead.

Manufacturer Narrative

Additional information is provided.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Additional information is provided.The received sample was found in a plastic bag with cover foil packed inside of bubble wrap.The tip of the instrument stuck out of the plastic bag.The device history record for the affected lot was reviewed.No abnormalities that could have contributed to this event were found and the product was released according to acceptance criteria.A 100% final inspection is performed for this product.The complaint history was reviewed two years back.It showed 41 (33 in (b)(6)) comparable complaints with the same damage (disrupted/detached/broken).The sample was visually inspected with the aid of a photomicroscope with various magnifications.The customer¿s complaint was confirmed.The soft tip is detached.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.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 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.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

Event Description

Additional information received has clarified that the detached soft tip portion was successfully removed from the patient's eye during a second, separate procedure and the patient is fully recovered.

• 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: 7712156
• MDR Text Key: 114949420
• Report Number: 3003398873-2018-00017
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2018
• Is this an Adverse Event Report?: Yes
• 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: 09/12/2018
• Date Manufacturer Received: 05/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SF6 GAS
• Patient Outcome(s): Other
• Patient Age: 41 YR