MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. BLADELESS TROCAR WITH STABILITY SLEEVE; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Catalog Number B5LT

Device Problem Material Distortion (2977)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/25/2015

Event Type  malfunction  

Event Description

It was reported that during a lap sigmoidectomy, it was found that the tip of the device was distorted through a viewing endoscope.Another device was used to complete the case.There were no adverse consequences to the patient.

Manufacturer Narrative

(b)(4).Should the information be provided later, a supplemental medwatch will be sent.The analysis results found that only the sleeve assembly from a b5lt device was returned for analysis.As the obturator was not returned, we were unable to investigate further the reported incident; however the sleeve was observed to be damaged at the tip.Upon visual inspection with magnification, the sleeve was noted to be melted.See pictures.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.

• Brand Name: BLADELESS TROCAR WITH STABILITY SLEEVE
• 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 0096 9
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 4695295
• MDR Text Key: 5640456
• Report Number: 3005075853-2015-02362
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K032676
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: B5LT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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