MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. BASX BLADELESS TROCAR 5MM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	TB5LT
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # unk.Product was not returned.Based on the information available, it has been determined that no corrective and preventive action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.The lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.Additional information received: a photo was received for review.Review is in progress and has not yet been completed.Upon completion of photo review, a supplemental medwatch will be sent.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that during laparoscopic hepatectomy surgery , noted the device was damaged (trocar canula was broken).Another device was used to complete the surgery.  there were no adverse consequences to the patient.No additional information could be provided. .
Additional Manufacturer Narrative
(b)(4).Additional information received: a photo was received for review.During the visual analysis, the following was observed: the photo shows a device with stopcock and the outer seal assembled.The sleeve can be seen broken.Based on the photo review, the event described could be confirmed, however no conclusion or root cause could be determined.Because the instrument was not returned, our evaluation is limited.An analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing documentation could not be completed as the lot number was not provided.As part of our quality process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.If the product or additional information is received at a later date, the investigation will be updated as applicable.

• Brand Name: BASX BLADELESS TROCAR 5MM
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 11996981
• Report Number: 3005075853-2021-03319
• Device Sequence Number: 3410611
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2021

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: TB5LT
• Device Catalogue Number: TB5LT
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/24/2021
• Supplement Date Received by Manufacturer: 07/26/2021
• Initial Report FDA Received Date: 06/15/2021
• Supplement Report FDA Received Date: 08/13/2021
• Patient Sequence Number: 1