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

Model Number PSEE45A

Device Problems Failure to Advance (2524); Failure to Cut (2587)

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

Event Date 08/03/2018

Event Type  malfunction  

Event Description

When using echelon flex powered plus 45mm stapler, staple line completed accurately; however, the blade did not cut to the end of the staple line- resulting in using multiple staple reloads and a potential unsafe condition.Manufacturer response for stapler, (brand not provided) (per site reporter): unknown.

• Brand Name: ECHELON FLEX
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC; 4545 creek rd.; cincinnati OH 45242
• MDR Report Key: 8109875
• MDR Text Key: 128572913
• Report Number: 8109875
• 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: 11/12/2018

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 Model Number: PSEE45A
• Device Catalogue Number: PSEE45A
• Device Lot Number: A000441POIO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/12/2018
• Event Location: Hospital
• Date Report to Manufacturer: 11/28/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 8030 DA
• Patient Weight: 75