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

Model Number B12LT

Device Problems Crack (1135); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/24/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # x94z8m.Investigation summary the product was returned to ethicon for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that b12lt device was returned outside its package opened and with the obturator inserted through the sleeve, for this reason the seal mechanism was found to be deformed.In an attempt to replicate the reported incident, the device was visually tested to detect any sleeve issues.Upon evaluation of the device, the sleeve was found fully functional according to the manufacturing requirements.The package was visually inspected and no damaged was observed.The event described could not be confirmed as the device performed without any difficulties noted.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.As part of ethicon¿s quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device lot and batch number, and no non-conformances were identified.

Event Description

It was reported that during an unknown procedure, the sleeve fell off after opening the packing.Changed to a new one to complete surgery.There was no patient consequence reported.

Manufacturer Narrative

(b)(4).Date sent: 1/6/2023.D4: batch # x94z8m this is an analysis of the photo submitted to ethicon endo surgery for evaluation.During the visual analysis the following was observed: a b12lt device with its packaging open and the obturator inserted through the sleeve.Based on the pi-16696659584353196 review, the event described packaging device issue and sleeve issue not confirmed.Please refer to the device analysis for full analysis details and conclusion.As part of the ethicon endo surgery quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device lot and batch number, and no non-conformances were identified.

• 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: 16006571
• MDR Text Key: 308114809
• Report Number: 3005075853-2022-08767
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 01/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B12LT
• Device Catalogue Number: B12LT
• Device Lot Number: 829A51
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 12/15/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/23/2022
• Initial Date FDA Received: 12/19/2022
• Supplement Dates Manufacturer Received: 12/20/2022
• Supplement Dates FDA Received: 01/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1