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

Model Number B12LT

Device Problem Material Integrity Problem (2978)

Patient Problem Insufficient Information (4580)

Event Date 10/23/2022

Event Type  Injury  

Event Description

It was reported that during a laparoscopic colostomy with distal wash out procedure, the device was inserted into the patient and said product was used as according to ifu and removed from patient after surgery.However, as patient went in for a second procedure, a diagnostic laparoscopic procedure with refashioning of sigmoid colostomy, a black color foreign material was found inside the patient.Upon removal and inspection, surgeon suspected it was a fragment from the xcel trocar universal seal.No complications were reported for the patient during the time the foreign matter part was left in or after removal.

Manufacturer Narrative

(b)(4).Batch # unk.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: "-how long was the foreign matter left in the patient? (time period between initial operation and second operation) -could you please provide a comprehensive list of instruments that passed through the trocar during the initial procedure? -was any mesh passed through the trocar during the initial procedure? -were any towels, raytec, or 4x4 gauze passed through the trocar during the initial procedure? -did the patient present with any complications believed to be associated with the foreign body left behind? -will the device and/or the fragment that was left in the patient be returned?" 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.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

(b)(4).Date sent: 1/11/2023.This is an analysis of a photo submitted to ethicon for evaluation.During the visual analysis the following was observed: the photo shows the fully disassembled seal universal component.Unfortunately the photo does not provide enough evidence to determine the root cause.Based on the photo review, the event describe is confirmed, however no conclusion or root cause could be determined.Hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.Because the instrument was not returned our evaluation is limited.As part of ethicon quality process all devices are manufactured, inspected, and released to approved specifications.The manufacturing records could not be reviewed as the batch number is unknown.

• 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: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 16008767
• MDR Text Key: 305782070
• Report Number: 3005075853-2022-08780
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: MY
• 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
• Report Date: 01/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: B12LT
• Device Catalogue Number: B12LT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/25/2022
• Initial Date FDA Received: 12/19/2022
• Supplement Dates Manufacturer Received: 12/20/2022
• Supplement Dates FDA Received: 01/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other