MAUDE Adverse Event Report: ETHICON ENDOSCOPIC LINEAR CUTTER; STAPLER SURGICAL

Model Number REF#PSEE60A

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Information (3190)

Event Date 11/17/2017

Event Type  malfunction  

Event Description

Surgical stapler used twice then handed for reloading.Stapler wiped off and staff member went to reload when stapler broke into two pieces.New device obtained.

• Brand Name: ENDOSCOPIC LINEAR CUTTER
• Type of Device: STAPLER SURGICAL
• Manufacturer (Section D): ETHICON; guaynabo PR 00969
• MDR Report Key: 7174566
• MDR Text Key: 96870279
• Report Number: MW5074462
• 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: Nurse
• Type of Report: Initial
• Report Date: 01/05/2018

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: 03/31/2020
• Device Model Number: REF#PSEE60A
• Device Catalogue Number: PSEE60A
• Device Lot Number: P92585
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/08/2018
• 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: 61 YR
• Patient Weight: 91