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 Consequences Or Impact To Patient (2199)

Event Date 12/14/2019

Event Type  Injury  

Manufacturer Narrative

No sample or lot number information has been received by manufacturing for evaluation.As the affected lot is unknown, 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.The sample is not available for investigation because it was discarded therefore, damage cannot be confirmed or rather a root cause cannot be identified.The manufacturer internal reference number is: (b)(4).

Event Description

A physician reported that the silicone tip of an ophthalmic backflush device detached into a patient's eye during vitrectomy surgery and was retained inside of the eye.An additional surgical procedure was required and performed in order to remove the detached tip from inside of the eye.There was no harm to the patient.Additional information received further clarified that the detached device tip was removed from the eye during a separate surgery that was performed on a later date.Additional information has been requested.

Event Description

Additional information was received whereby the surgeon confirmed complete removal of the foreign material and stated that the event was assessed as non serious with causality unknown.The patient's condition was further reported as recovered.

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: 9553448
• MDR Text Key: 174292034
• Report Number: 3003398873-2020-00005
• 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: 01/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 12/25/2019
• Initial Date FDA Received: 01/06/2020
• Supplement Dates Manufacturer Received: 01/09/2020
• Supplement Dates FDA Received: 01/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other