MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC ECHELON FLEX; STAPLE, IMPLANTABLE

Model Number PSEE60A

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/27/2022

Event Type  malfunction  

Event Description

An elderly patient was undergoing a video assisted thoracotomy (vats) on the right middle lobe when during the resection the linear cutter stopped halfway.The attending surgeon had to manually reverse the knife blade.No harm or adverse outcomes was associated with this event to the patient.Echelon linear cutter ref psee60a with lot#x94uoy.Reload gst60t with lot 686a38 or 32a00 was used.Team was unable to determine which reload was used as two were opened on the table.The linear cutter was released to the company.Manufacturer response for linear cutter, echelon linear cutter (per site reporter): pending response.

• Brand Name: ECHELON FLEX
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 00969
• MDR Report Key: 15426756
• MDR Text Key: 299944550
• Report Number: 15426756
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/07/2022,06/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PSEE60A
• Device Catalogue Number: PSEE60A
• Device Lot Number: X94UOY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/07/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/15/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 29565 DA
• Patient Weight: 61 KG
• Patient Race: White