MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. BASX BLADELESS TROCAR 12MM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number TB12LT

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/17/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # unk.A manufacturing record evaluation was performed for the finished device lot number and no non-conformances were identified.Additional information: a photo was received for review.Review is still in progress and has not yet been completed.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event 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.

Manufacturer Narrative

(b)(4).Date sent: 10/6/2020 d4: batch # u40a60 investigation summary the analysis results found that a tb12lt device was returned inside the package without apparent damage.Upon visual inspection, the seal area of the blister was not completely sealed, however this defect did not compromise the product sterility.This condition is related to the manufacturing process.Additional information: upon visual inspection of one photo, the following was observed: the photo shows a device inside of its package partially open.Also, the seal area appears to be complete.Based on the photo alone the event described cannot be confirmed.Please refer to the device analysis for full analysis details and conclusion.It should be noted that as part of our quality process all  devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.

• Brand Name: BASX BLADELESS TROCAR 12MM
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 10480759
• MDR Text Key: 206128915
• Report Number: 3005075853-2020-04460
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10705036003007
• UDI-Public: 10705036003007
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TB12LT
• Device Catalogue Number: TB12LT
• Device Lot Number: U40A60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2020
• Date Manufacturer Received: 09/18/2020
• Patient Sequence Number: 1