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	07/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # unk.Additional information received: a photo has been received for review.Review of photo is in progress but has not yet been completed.A manufacturing record evaluation was performed for the finished device lot number and no non-conformances were identified.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.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 an unknown procedure, before used on the patient, noted the packing was damaged.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).Date sent: 8/31/2020.Investigation summary the analysis results found that a tb5lt device was returned inside the package without apparent damage.In addition, the package was reviewed and the seal area was noted to be complete.The event could not be confirmed as the seal area was noted to be completed.In addition, a photo was received for review.Upon visual inspection of one photo, the following was observed: the photo shows a package from top view partially open.However, the seal area cannot be observed.Based on the photos the event describe is confirmed; however, no conclusion or root cause could be determined.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.

• 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: 10395485
• Report Number: 3005075853-2020-04088
• Device Sequence Number: 2508923
• 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,Followup
• Report Date (Section B): 07/16/2020

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: 01/31/2025
• Device Model Number: TB5LT
• Device Catalogue Number: TB5LT
• Device Lot Number: U40336
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2020
• Initial Date Received by Manufacturer: 07/16/2020
• Supplement Date Received by Manufacturer: 08/12/2020
• Initial Report FDA Received Date: 08/12/2020
• Supplement Report FDA Received Date: 08/31/2020
• Patient Sequence Number: 1