MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, INC. ENDOPATH; STAPLE, IMPLANTABLE

Catalog Number ATS45

Device Problems Defective Component (2292); Device Operates Differently Than Expected (2913)

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

Event Date 07/24/2012

Event Type  malfunction  

Event Description

The dr was performing a laparoscopic appendectomy when the ats45 endopath stapler failed to operate properly.Stapler was immediately removed from procedure and taken out of service.A new stapler was used without further incident.Defective stapler placed in red bag and placed at or desk.

• Brand Name: ENDOPATH
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, INC.; 4545 creek road; ml 120a; cincinnati OH 45242
• MDR Report Key: 6089075
• MDR Text Key: 59474331
• Report Number: 6089075
• Device Sequence Number: 1
• Product Code: GDW
• 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: Nurse
• Type of Report: Initial
• Report Date: 09/30/2016

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: Physician
• Device Catalogue Number: ATS45
• Device Lot Number: N4LJ6E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/30/2016
• Event Location: Hospital
• Date Report to Manufacturer: 09/30/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/09/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO
• Patient Age: 29 YR
• Patient Weight: 70