MAUDE Adverse Event Report: COVIDIEN ARGYLE

Model Number 8888571059

Device Problem Material Too Rigid or Stiff (1544)

Patient Problem Pneumothorax (2012)

Event Date 02/13/2017

Event Type  Injury  

Manufacturer Narrative

An investigation is currently under way; upon completion the results will be forwarded.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer reports the device was very hard/rigid therefore lungs damage was seen.Patient outcome: pneumothorax, but the current patient condition is okey/fine.The customer stated " the device was changed with the new order.They were using the device with the brown cover/cap and the customer was glad from the hardness and the angle of curvature of the device, but now they received the same device with the red cover/cap and the customer had the complaint / dissatisfaction because of the device's hardness and product fold angle.Details of the lung damage were not provided due to patient information confidentiality.

Manufacturer Narrative

There were no samples submitted with this complaint.The complaint shall be reopened if a sample is received.The device history record (dhr) file was reviewed indicating that product was released meeting all quality standard requirements.Because a sample was not provided for evaluation a root cause could not be determined.However an investigation was performed to analyze different perspectives about the origin or causes of the described condition.The root cause could not be determined for this incident.The process is running according to product specifications meeting quality acceptance criteria.We will continue monitoring the process for any adverse trends that require immediate attention.A sample has not been returned and due to the dated complaint, it is not conceivable that a sample would still be available however if one has been retained, please let us know and we will provide details for the product return.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ARGYLE
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad; tijuana,na 92173 ; MX 92173
• Manufacturer (Section G): COVIDIEN; calle 9 sur no. 125 cuidad; tijuana,na 92173 ; MX 92173
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6406213
• MDR Text Key: 70004158
• Report Number: 9612030-2017-05034
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Reporter Country Code: TU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 11/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2021
• Device Model Number: 8888571059
• Device Catalogue Number: 8888571059
• Device Lot Number: 625724264X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/14/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other