MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. BASX BLADELESS TROCAR 12MM

Model Number	TB12LT
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown procedure, the tip of trocar ruptured during the surgery.There were no adverse consequences to the patient.No additional information could be provided.
Additional Manufacturer Narrative
(b)(4).Date sent: 4/5/2023.D4: batch # x9619t.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?" an analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.However, if the product or product id numbers are received at a later date, the investigation will be updated as applicable.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.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.
Additional Manufacturer Narrative
(b)(4).Date sent: 5/19/2023.D4: batch # 151c26.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.

• Brand Name: BASX BLADELESS TROCAR 12MM
• Common Device Name: BASX BLADELESS TROCAR 12MM
• 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: 16680883
• Report Number: 3005075853-2023-02228
• Device Sequence Number: 7209674
• Product Code: GCJ
• UDI-Device Identifier: 10705036003007
• UDI-Public: 10705036003007
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2023

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
• Operator of Device: Health Professional
• Device Model Number: TB12LT
• Device Catalogue Number: TB12LT
• Device Lot Number: 151C26
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/07/2023
• Supplement Date Received by Manufacturer: 04/25/2023
• Initial Report FDA Received Date: 04/05/2023
• Supplement Report FDA Received Date: 05/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/21/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown