MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, INC. ENDOPATH XCEL; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number B5LT

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/25/2017

Event Type  malfunction  

Event Description

During procedure the b5lt trocar was inserted but it was not smooth upon entrance.Surgeon requested trocar be returned to the company for examination.The patient was not harmed.Manufacturer response for trocar, b5lt trocar (per site reporter): sales rep contacted with the issue and returned to them.

• Brand Name: ENDOPATH XCEL
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, INC.; 4545 creek rd.; ml 120a; cincinnati OH 45242
• MDR Report Key: 6826727
• MDR Text Key: 83864125
• Report Number: 6826727
• Device Sequence Number: 1
• Product Code: GCJ
• 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: 08/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: B5LT
• Device Catalogue Number: B5LT
• Device Lot Number: 41X31
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/16/2017
• Event Location: Hospital
• Date Report to Manufacturer: 08/16/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/29/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: OCCURRED DURING EXPLORATORY LAPAROSCOPY WITH APPEN