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

Catalog Number 337.88

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/03/2015

Event Type  malfunction  

Event Description

A surgeon reported that a softtip became disconnected in the patient´s eye when the softip was inserted through the trocar.The reporter informed that a long time was necessary to pick up the softip with two forceps and to get it out from the eye.No patient harm occurred.Additional information has been requested but not received to date.

Manufacturer Narrative

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 but not received to date.

Event Description

Additional information was received from the surgeon who reported that breaking of the soft tip occurred during taking out the silicone-soft-tip-vacuum cleaner.In surgeon's opinion, the device contributed to the event.Per surgeon, the "pinned" soft-tip upper part could have broken off much more easily due to tilting during insertion.The soft tip upper part got caught in front of the trocar and in the eye.

Manufacturer Narrative

Evaluation summary: a sample was not received for evaluation.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 manufacturer¿s acceptance criteria.A 100% final inspection is performed for this product.The directions for use (dfu) describes: be cautious using soft tip instruments in combination with valved entry systems (valved cannula).Soft tip may kink and be damaged during insertion of soft tip.A root cause cannot be ascertained because the damage cannot be confirmed without receiving a sample for investigation.Various causes are possible for this kind of potential damage.

Manufacturer Narrative

Correction: a supplemental medical device report (smdr) # 3 is being filed to correct the date received by mfr on the prior filed initial/supplemental report.Incorrect date of 03/18/2015 is being corrected to 04/16/2015.(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
• Manufacturer (Section G): ALCON GRIESHABER AG; winkelriedstrasse 52; schaffhausen 8203 ; SZ 8203
• Manufacturer Contact: janet moran ; 6201 south freeway; mail stop r3-48; fort worth, TX 76134 ; 8176152742
• MDR Report Key: 4572838
• MDR Text Key: 5478932
• Report Number: 3003398873-2015-00506
• Device Sequence Number: 1
• Product Code: HQE
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K884043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,foreign,health profe
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2015
• Is this an Adverse Event Report?: No
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other