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

Catalog Number 8065751493

Device Problem Device Slipped (1584)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/30/2017

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.(b)(4).

Event Description

A customer reported that the green rubber piece slipped off the metal part of the trocar valve during an eye surgery.The metal part of the trocar valve was found outside the eye.The procedure was completed without harm to the patient.Additional information and product sample were requested for this event.

Manufacturer Narrative

Three opened trocars were received in a tray for evaluation.The returned samples were visually inspected.Two samples were found conforming and one sample was non-conforming with the hub and cannula returned separated.Adhesive was present inside of the hub.A photo of the products is attached to the parent complaint and has been reviewed by the investigation site.Two full trocar assemblies can be seen as well as one separated trocar.A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.A complaint history examination indicates there are no additional complaints associated with the lot for the reported issue.During assembly of the trocar product adhesive is dispensed at the cannula hub interface.The evaluation of the returned non-conforming sample identified adhesive inside of the hub, therefore, how and when the trocar cannula and hub became separated cannot be determined from this evaluation and the root cause for this complaint is unknown.A potential contributing factor of the separation is manipulation during surgery.The exact root cause for this complaint is unknown, therefore, specific action with regards to this complaint cannot be taken.(b)(4).The manufacturer internal reference number is: (b)(4).

• 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: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 6508189
• MDR Text Key: 73494767
• Report Number: 2028159-2017-01712
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: 8065751493
• Device Lot Number: 16019398X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2016
• 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
• Treatment: TROCAR VALVE
• Patient Outcome(s): Other