MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC POWERED PLUS LONG ARTICULATING ENDOSCOPIC LINEAR CUTTER

Catalog Number PLEE60A

Device Problems Self-Activation or Keying (1557); Failure to Auto Stop (2938)

Patient Problem No Information (3190)

Event Date 06/20/2018

Event Type  malfunction  

Event Description

Surgeon was performing a gastric sleeve and uses a powered plus long articulating endoscopic linear cutter.The surgeon gradually activated the device to cut the tissue.When the surgeon released the handle of the device, it did not stop and continued to cut the tissue he was cutting.

• Brand Name: POWERED PLUS LONG ARTICULATING ENDOSCOPIC LINEAR CUTTER
• Type of Device: LINEAR CUTTER
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC; guaynabo PR 00969
• MDR Report Key: 7633785
• MDR Text Key: 112344331
• Report Number: MW5078027
• 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: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/21/2018

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 Expiration Date: 12/31/2020
• Device Catalogue Number: PLEE60A
• Device Lot Number: R9234Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/22/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Weight: 51