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

Model Number	TB5LT
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # u4026v.Investigation summary: the analysis results found that a (b)(4) device was returned inside the package.The packaged was returned partially open from "peel here" area, the seal area was noted to be complete.Event could not be confirmed as the seal area was complete.In addition, two photos were also received for review.Upon visual inspection of two photos, the following was observed: the first photo shows a trocar inside of its package with product code (b)(4), lot # u4026v.The second photo shows a package from top view and it can be seen to be partially opened, however, the seal area could not be observed.Based on the photos no conclusion could be reached as to what may have caused the reported incident, the assignable cause of the reported complaint could not be determined.Please refer to the device analysis for full analysis details and conclusion.A manufacturing record evaluation was performed for the finished device lot/batch number, and no non-conformances were identified.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
Damaged packaging.It was reported that during an unknown stomach surgery, before used on the patient, noted the packing was damaged(as the photo shows.) another device was used to complete the surgery.There were no adverse consequences to the patient.No additional information could be provided.

• 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 ; * 00969
• MDR Report Key: 10242198
• Report Number: 3005075853-2020-03395
• Device Sequence Number: 11419266
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/14/2020

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: 12/31/2024
• Device Model Number: TB5LT
• Device Catalogue Number: TB5LT
• Device Lot Number: U4026V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/14/2020
• Initial Report FDA Received Date: 07/07/2020
• Patient Sequence Number: 1