MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. BASX BLADELESS TROCAR 5MM

Model Number	TB5LT
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown procedure and during the trocar entry the low-housing profile part of trocar was broken.
Additional Manufacturer Narrative
(b)(4).Batch #: u95295.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 tb5lt device was returned with the sleeve cap separated and was observed to be welded.As part of ethicon¿s quality process, all devices are manufactured, inspected, and released to approved specifications.It should be noted that product failure is multifactorial.Based on the information currently available, a product issue was identified during the investigation of the sample received.This product issue will be addressed through ethicon¿s quality system.A manufacturing record evaluation was performed for the finished device batch number u95295, and no non-conformances were identified.A manufacturing record evaluation was performed for the finished device, tb5lt lot number u40k5j, and no non-conformances were identified.Manufacturing date: 09/04/2020, expiration date 08/31/2025.Additional information was requested, and the following was obtained: were there any patient consequences? if yes, please describe.-no consequences was with the patient.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: BASX BLADELESS TROCAR 5MM
• Common Device Name: BASX BLADELESS TROCAR 5MM
• 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: orla o'mahony ; 475 calle c; guaynabo ; *
• MDR Report Key: 14078978
• Report Number: 3005075853-2022-02245
• Device Sequence Number: 12059926
• Product Code: GCJ
• UDI-Device Identifier: 10705036003021
• UDI-Public: 10705036003021
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/11/2022

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 Expiration Date: 08/31/2025
• Device Model Number: TB5LT
• Device Catalogue Number: TB5LT
• Device Lot Number: U40K5J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/21/2022
• Initial Report FDA Received Date: 04/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown