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

Catalog Number 8065751902

Device Problem Sticking (1597)

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

Event Date 02/16/2018

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.(b)(4).

Event Description

A nurse reported a product got stuck in the trocar during a procedure.Patient impact information is not known.

Manufacturer Narrative

Probe: one opened probe was received with a tip protector in a bubble bag for the report of probe got stuck in trocar.The trocar cannula/hub assembly was on the probe needle.The returned probe sample was visually inspected and found non-conforming.Foreign matter was observed on the needle and in the port.The probe needle was fit tested for function through a ring gauge and was found non-conforming.The probe needle did not go through the ring gage under its own weight.The foreign material was wiped off and then the probe needle was fit tested again with the ring gauge and was found conforming.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 is one additional complaint associated with the lot for the reported issue.The complaint evaluation does confirm the probe had a product fit issue.The fit issue was due to the foreign material on the needle, which is possibly surgical residue.The exact source of the foreign material cannot be determined from this evaluation, however it does not point to a manufacturing issue due to the foreign material easily wiping off.All probes are 100% visually inspected during the manufacturing process for excessive manufacturing materials on the needle.All assembled probe needle diameters are also 100% tested for fit into a ring gauge to insure the probe needle does not exceed a trocar opening.Trocar: one opened trocar cannula/hub assembly was received on a probe needle for the report of probe stuck in trocar.The sample was visually inspected and was found to be non-conforming with foreign material on the outer diameter (od) and internal diameter (id) of the trocar cannula.After the trocar cannula was cleaned it was dimensionally inspected for cannula id and was found conforming.The sample was then functionally tested for fit with the returned probe and was found conforming.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.The returned sample was found to be conforming, therefore a product fit issue as described in the complaint was not confirmed and a root cause cannot be determined for the complaint as described by the customer.No specific action with regard to this complaint was taken because both products met specification once the foreign material was removed.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

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

Event Description

The nurse indicated the product was replaced with another and the procedure was completed.There was no harm to the patient.

• 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: 7345329
• MDR Text Key: 102731501
• Report Number: 1644019-2018-00053
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 06/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: 8065751902
• Device Lot Number: 2094146H
• Other Device ID Number: 380657519026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/27/2017
• 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