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

Catalog Number B12XT

Device Problems Break (1069); Melted (1385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/08/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.We did not receive a batch or lot number for the product involved in this complaint.Therefore, we were unable to check manufacturing records for any related non-conformance.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Can you confirm whether or not any piece or pieces of the trocar sleeve were broken off of the device? if yes, did any piece or pieces fall into the patient? if yes, were they retrieved? will any pieces be returned with the device for analysis? if not, were they disposed of?.

Event Description

It was reported that during a thyroid procedure, during surgery, scopy trocar 's shell tip is melted.Melted at first and then broken.There were two kind of heat source.One is harmonic blades and other one is a light source for scopy.There was no contact with the harmonic blades.There were no patient consequences.

Manufacturer Narrative

(b)(4).Additional information was requested and the following was obtained: can you confirm whether or not any piece or pieces of the trocar sleeve were broken off of the device? if yes, did any piece or pieces fall into the patient? if yes, were they retrieved? will any pieces be returned with the device for analysis? if not, were they disposed of? yes, some of piece broken and off device.One time, my customer as told me, little piece fall to patient but couldn¿t find out.It still retain patient.Noting return to company by broken and off trocar.Operation room nurse disposed when they were operating.Per photographic evaluation: upon visual inspection of the picture, a damage was noted to be in the tip of the trocar.The damage appears to be melted, this type of damage is consistent with the one produced by an energized device.The device appear to be completed with out missing plastic parts.However, no conclusion could be reached as to the origin of the damage as the device was not returned for analysis.The photos do not provide enough evidence to determine root cause.Hands on analysis should provide the evidence necessary to confirm the root cause.No lot number or batch number was provided to perform the dhr review.

Manufacturer Narrative

(b)(4).Batch # p9210m.Device analysis: the analysis results found that the b12xt instrument was received with the sleeve 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.

• 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: 6914569
• MDR Text Key: 89695724
• Report Number: 3005075853-2017-05292
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• PMA/PMN Number: K032676
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: B12XT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1