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

Catalog Number B12LT

Device Problem Material Integrity Problem (2978)

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

Event Date 11/01/2023

Event Type  malfunction  

Event Description

It was reported that during an unknown procedure, the seal was broken.

Manufacturer Narrative

(b)(4).Date sent: 12/22/2023.D4: batch # unk.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: "did any pieces fall into the patient? if yes, were they retrieved? will all pieces be returned with the device? if no, were they discarded? were there any patient consequences? if yes, please describe." 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: 2/5/2024.D4: batch # unk.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 only the sleeve from the b12lt device was returned without the universal seal and with no damage in the external components.In addition, the packaging opened was returned and the universal seal was returned inside a plastic bag.The device was visually evaluate the condition of the duckbill.Upon disassembling, the duckbill was found damaged and torn.In addition, the torn piece of the duckbill was returned inside a plastic bag.Per instructions for use: "use caution when introducing or removing instruments through the trocar sleeve in order to prevent inadvertent damage to the seals which could result in loss of pneumoperitoneum.Special care should be used when inserting sharp or angled edged endoscopic instruments to prevent tearing the seal." 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 382c36 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: 18383332
• MDR Text Key: 331496724
• Report Number: 3005075853-2023-09789
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10705036001164
• UDI-Public: 10705036001164
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: 02/05/2024

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: B12LT
• Device Lot Number: 382C36
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/28/2023
• Initial Date FDA Received: 12/22/2023
• Supplement Dates Manufacturer Received: 01/08/2024
• Supplement Dates FDA Received: 02/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1