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

Model Number B12SRT

Device Problems Manufacturing, Packaging or Shipping Problem (2975); Material Integrity Problem (2978)

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

Event Type  malfunction  

Event Description

It was reported that during an unknown procedure, it was found that the white part of the sleeve was off when the package was opened.Another device was used to complete the case.There were no adverse consequences to the patient.

Manufacturer Narrative

(b)(4).Batch # unk.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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: 1/19/2023 d4: batch # x95n6v 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 b12srt device was returned inside its package unopened and with the universal seal unlatch from the sleeve.In an attempt to replicate the reported incident, the device was functionally tested to detect any reducer attachment removal issues.Upon evaluation of the device, the universal seal latch onto the sleeve assembly.In addition the obturator latch onto the universal seal as well.The device was fully functional according to the manufacturing requirements.The event described could not be confirmed as the device performed without any difficulties noted.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 968a10 number, and no non-conformances were identified.A manufacturing record evaluation was performed for the finished device batch and lot 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: 16009956
• MDR Text Key: 307929899
• Report Number: 3005075853-2022-08783
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/19/2023

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: B12SRT
• Device Catalogue Number: B12SRT
• Device Lot Number: 968A10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/28/2022
• Initial Date FDA Received: 12/19/2022
• Supplement Dates Manufacturer Received: 01/02/2023
• Supplement Dates FDA Received: 01/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1