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

Catalog Number B5LT

Device Problem Crack (1135)

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

Event Date 07/25/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date sent: 8/24/2023.D4: batch # x9606m.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 b5lt device was returned with no apparent damage.In an attempt to replicate the reported incident, the device was functionally tested to detect any leaking issues.Upon evaluation of the device, it was functionally leak tested and passed.The device was visually inspected and no damaged found on the sleeve.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 batch and lot number, and no non-conformances were identified.

Event Description

It was reported that during a lap gastric sleeve procedure, the sleeve is not ridged and will bend when inserted into the abdomen, causing the harmonic device to not be able to insert smoothly.No patient consequences.

• 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 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 17612794
• MDR Text Key: 321850288
• Report Number: 3005075853-2023-06046
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10705036001225
• UDI-Public: 10705036001225
• 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
• Report Date: 08/24/2023

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 Catalogue Number: B5LT
• Device Lot Number: X9606M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2023
• Initial Date Manufacturer Received: 07/27/2023
• Initial Date FDA Received: 08/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1