MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - HOUSTON CONSTELLATION SURGICAL PROCEDURE PAK; GENERAL SURGERY TRAY (KIT)

Catalog Number 8065751617

Device Problem Sticking (1597)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/07/2018

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.The manufacturer internal reference number is: (b)(4).

Event Description

A customer reported the cutter got stuck in the trocar cannula during a procedure.The procedure was completed the same day and there was no harm to the patient.No additional information is expected.

Manufacturer Narrative

Additional information provided.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 were no additional complaints associated with the lot for the reported issue.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 3 additional complaints associated with the lot for the reported issue.No samples have been returned for evaluation for the report of the cutter stuck in trocar; therefore, the condition of the products could not be verified.No samples were returned and the device history record review of the lot number provided indicated product was released according to product¿s acceptance criteria, therefore, the root cause for the defect experienced by the customer could not be determined.No additional action is required at this time.The manufacturer internal reference number is: (b)(4).

• Brand Name: CONSTELLATION SURGICAL PROCEDURE PAK
• Type of Device: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): ALCON RESEARCH, LTD. - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer (Section G): ALCON RESEARCH, LTD. - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer Contact: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7345802
• MDR Text Key: 102738123
• Report Number: 1644019-2018-00054
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: 8065751617
• Device Lot Number: 2101061H
• Other Device ID Number: 380657516179
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/07/2018
• Initial Date FDA Received: 03/16/2018
• Supplement Dates Manufacturer Received: 05/07/2018
• Supplement Dates FDA Received: 05/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2017
• 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