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

Model Number B8LT

Device Problem Crack (1135)

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

Event Date 06/16/2023

Event Type  malfunction  

Event Description

It was reported that during an unk procedure, upon end of case trocar cracks appeared on sheath of port.Unknown if the surgery was delayed or completed successfully.No patient consequences reported.

Manufacturer Narrative

(b)(4).Date sent: 7/12/2023.D4: batch # unk.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.The lot/ batch history records were reviewed and certified by external manufacturing that the manufacturing criteria were met prior to the release of the equipment.Additional information was obtained: there was no adverse event to the patient there was no effect on surgery time/duration.I was told nothing fell into patient, they noticed the cracks after the case but nothing dislodged.No patient consequences.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: 8/13/2023.D4: batch # unk.Investigation summary: the analysis results found that the b8lt device was received with the clear lens broken.As each device is visually inspected and functionally tested during the manufacturing process, no conclusion could be reached as to what might have caused the reported event.No conclusion could be reached as to what might have caused the damage observed at analysis.The damaged on the clear lens, it is possible that the damaged was due to an improper handling of the device.A manufacturing record evaluation was performed for the finished device batch number a9c081, and no related 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: 17310624
• MDR Text Key: 319422668
• Report Number: 3005075853-2023-04873
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10705036001256
• UDI-Public: 10705036001256
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K032676
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/13/2023

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: B8LT
• Device Catalogue Number: B8LT
• Device Lot Number: 339C00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/19/2023
• Initial Date FDA Received: 07/12/2023
• Supplement Dates Manufacturer Received: 07/18/2023
• Supplement Dates FDA Received: 08/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1