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

Catalog Number B11LT

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/06/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # r92a0t.Device analysis: the analysis results found that the b11lt instrument was received with the sleeve broken and melted.This type of damage is consistent with the one produced by an energized device.In order to prevent this kind of damage please avoid the contact with laser, electrosurgical or ultrasonic devices.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.Additional information was requested and the following was obtained: did the tip of the trocar sleeve crack or break off? if yes, did any pieces of the device fall into the patient? if yes, how was the piece of the device retrieved? was there any patient consequence? if yes, please explain.It does not appear that any part of the trocar sleeve had broken off but it does look like the plastic has mishapen as if it had got hot and melted! it is not thought any pieces of the device fell into the patient.

Event Description

Misshapen tip to stability sleeve.Noted when passing the telescope through the sleeve after insertion into the patient.

• Brand Name: ENDOPATH XCEL BLADELESS TROCAR
• Type of Device: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: milton garrett ; 475 calle c; guaynabo 00969 ; 5133378865
• MDR Report Key: 7852554
• MDR Text Key: 119655492
• Report Number: 3005075853-2018-12532
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 20705036001123
• UDI-Public: 20705036001123
• Combination Product (y/n): N
• PMA/PMN Number: K032676
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: B11LT
• Device Lot Number: R4042U
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2018
• Date Manufacturer Received: 08/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1