MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER ACCURUS SURGICAL SYSTEM PROCEDURE PAK; GENERAL SURGERY TRAY (KIT)

Catalog Number 8065750814

Device Problems Leak/Splash (1354); Failure to Deliver (2338)

Patient Problem No Code Available (3191)

Event Date 02/13/2016

Event Type  malfunction  

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.A non-safety medical device correction was completed on august 12, 2015 and a manufacturing change implemented to address the root cause.All potentially impacted alcon customers have been contacted, trocar plugs made available and other risk mitigations discussed.Additional information has been requested.(b)(4).

Event Description

A nurse reported that leaking 23g trocars had caused patient's right eye to get soft during surgery.The auto stop tap (3 way green tap) within the same pak then failed and was also leaking before infusion was connected.Airline attached also failed and was not delivering air and the patients eye collapsed.The procedure could be completed by opening another pak.The patient did not experienced any harm.The event caused surgeon stress.Additional information was received from the reporter.The affected eye was the right one.The procedure was a pars plana vitrectomy (ppv) for retinal detachment and was completed using 2 extra bottles of bss.It caused an extra hour of surgery delay.The patient will require more follow up appointments due to the inflammation.It is unknown if the inflammation was caused because of the event.Additional information has been requested.

Event Description

A correction is neccesary, the trocars were non-valved.

Manufacturer Narrative

Evaluation summary: the device history record showed the pack was released per specifications.The customer did not retain a sample for this complaint report; visual inspection or functional testing could not be conducted.The final customer trocars lot number was identified.For this final lot, four 23 ga entry component lots were used to make up the final lot.A device history record review for each of the components lots was conducted.The lots had no anomalies found based on the device history record reviews.The product was released based on the product's acceptance criteria.Because no sample was returned and the device history record reviews of the lot numbers provided indicated products were released according to product¿s acceptance criteria, the root cause for the defect experienced by the customer could not be determined.A potential root cause could be related to an error in the supplier's manufacturing process.

• Brand Name: ACCURUS SURGICAL SYSTEM PROCEDURE PAK
• Type of Device: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer (Section G): ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer Contact: eddie darton, md, jd ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175686660
• MDR Report Key: 5494413
• MDR Text Key: 40327039
• Report Number: 2028159-2016-01086
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065750814
• Device Lot Number: 15027567X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2015
• 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
• Patient Age: 68 YR