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

Model Number B5LT

Device Problem Material Integrity Problem (2978)

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

Event Date 01/31/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # unk.A manufacturing record evaluation was performed for the finished device lot number and no non-conformances were identified.Additional information was requested and the following was obtained: "did any pieces fall into the patient? no.If yes, were they retrieved?- will all pieces be returned with the device? yes.If no, were they discarded? were there any patient consequences? no." 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.

Event Description

It was reported that during a laparoscopic appendicectomy procedure, when the surgeon tried to pull out a tissue, the duckbill seal attachment broke off from the sleeve.Procedure delayed 10 minutes.No patient consequences.

Manufacturer Narrative

(b)(4).Date sent: 3/17/2023.D4: batch # u93193.Investigation summary: the product was returned to ethicon for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample revealed that the b5lt device was returned with the stability sleeve assembly with the housing component.In addition, the deep cone, duckbill and stopcock assembly were returned inside a plastic bag.The cap was not returned.No conclusion could be reached as to what might have caused the reported event.The reported complaint was confirmed.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.

• 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: 16417847
• MDR Text Key: 309995849
• Report Number: 3005075853-2023-01092
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10705036001225
• UDI-Public: 10705036001225
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K032676
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/17/2023

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: B5LT
• Device Catalogue Number: B5LT
• Device Lot Number: U4013V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/31/2023
• Initial Date FDA Received: 02/22/2023
• Supplement Dates Manufacturer Received: 02/24/2023
• Supplement Dates FDA Received: 03/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/09/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1