MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, INC. ECHELON FLEX; STAPLER, SURGICAL

Model Number EC45A

Device Problems Difficult to Remove (1528); Mechanical Jam (2983)

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

Event Date 02/21/2017

Event Type  malfunction  

Event Description

Device locked on the tissue, making it difficult to release.

• Brand Name: ECHELON FLEX
• Type of Device: STAPLER, SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, INC.; 4545 creek rd.; ml 120a; cincinnati OH 45242
• MDR Report Key: 6562783
• MDR Text Key: 75008507
• Report Number: 6562783
• Device Sequence Number: 1
• Product Code: GAG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: EC45A
• Device Catalogue Number: EC45A
• Device Lot Number: N92321
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/21/2017
• Event Location: Hospital
• Date Report to Manufacturer: 04/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 39 YR