MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENDOPATH** XCEL*; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Catalog Number B15LT

Device Problem Fitting Problem (2183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/20/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # n9151j.The analysis results found that the b15lt device was returned with no damaged in the external components and out of its sterile package.During the evaluation of the instrument, the obturator was inserted into the sleeve assembly and upon insertion it was confirmed that the obturator did not go through the universal seal as intended.The universal seal was measured and it belongs to a 12mm device.The condition of the incorrect component is related to the manufacturing process.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.

Event Description

It was reported that during a laparoscopic sleeve procedure, when the tech opened the trocar, he noticed that the obturator did not fit down the cannula.Apparently, the correct cannula was packaged but the reducer cap is too small.Although it is labeled "15".It is not.The reducer is an "11" or "12" but was labeled as "15".Case completed with another device of the same product code.There were no patient consequences reported.

• Type of Device: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo PR 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 00969
• Manufacturer Contact: milton garrett ; 4545 creek road ml 120a; cincinnati, OH 45242 ; 5133378865
• MDR Report Key: 5924537
• MDR Text Key: 53833560
• Report Number: 3005075853-2016-04986
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032676
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/20/2021
• Device Catalogue Number: B15LT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1