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

Catalog Number	TB5LT
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date of event: only event year known: 2018.Batch # unk.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.A manufacturing record evaluation was performed for the finished device lot number r40n40, and no non-conformances were identified.
Event or Problem Description
It was reported that the packing was damaged when the received at the distributor.Not involved in any surgery.No additional information could be provided.
Additional Manufacturer Narrative
(b)(4).Batch # r93u6e.Per photographic evaluation: upon visual inspection of a photo, the following was observed: the photo shows a plastic bag from top view slightly open with a device inside of the bag.Based on the photo alone the event describe is confirmed, however no conclusion or root cause could be determined.Please refer to the device analysis for full analysis details and conclusion.Device analysis: the analysis results found that a tb5lt device was returned outside its original package and no packaging was returned for analysis.Due to the condition of no packaging returned for analysis, no visually inspected could be performed to evaluate the incident reported.It could not be determined what may have cause the reported event.No conclusion could be reached as to what may have caused the reported incident.A manufacturing record evaluation was performed for the finished device batch r93u6e 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: 8499663
• Report Number: 3005075853-2019-17940
• Device Sequence Number: 13914941
• 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: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2019

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: 06/30/2023
• Device Catalogue Number: TB5LT
• Device Lot Number: R40N40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2019
• Initial Date Received by Manufacturer: 03/19/2019
• Supplement Date Received by Manufacturer: 04/11/2019
• Initial Report FDA Received Date: 04/10/2019
• Supplement Report FDA Received Date: 05/03/2019
• Patient Sequence Number: 1