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 Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Manufacturer Narrative

No sample or lot number information has been received by manufacturing for evaluation.As the affected lot is not known, the device history record could not be reviewed, but a 100% final inspection is performed for this product.A root cause cannot be ascertained because the damage cannot be confirmed without receiving a sample for investigation.A possible root cause could be due to external impact.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.A malfunction of the device could not be determined.As the sample is not available for investigation, damage cannot be confirmed or rather a root cause cannot be identified.Should a sample return, this file will be reopened and the sample investigated.(b)(4).

Event Description

A physician 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, but with no report of any patient harm.Additional information received indicates that a procedure will soon be planned in order to remove the detached tip from the eye.No such procedure is scheduled at this time.There is no change in the patient's current status.

Event Description

Additional information has been received which clarified that the retained cannula tip has been subsequently removed from the patient's eye.No patient problems were experienced.

Manufacturer Narrative

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: 8666005
• MDR Text Key: 147048570
• Report Number: 3003398873-2019-00042
• 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: 10/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 337.88
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other