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	10/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # unk.An analysis of the product could not be performed since a physical sample was not received for evaluation.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.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 is received at a later date, the investigation will be updated as applicable.
Event or Problem Description
It was reported that during an unknown procedure, before used on the patient, noted the device was broken (sleeve issue).Another device was used to complete the surgery.There was no patient consequence reported.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: 12749958
• Report Number: 3005075853-2021-06644
• Device Sequence Number: 11139680
• Product Code: GCJ
• UDI-Device Identifier: 10705036003021
• UDI-Public: 10705036003021
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/03/2021

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 Expiration Date: 09/30/2024
• Device Model Number: TB5LT
• Device Catalogue Number: TB5LT
• Device Lot Number: T4100F
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/12/2021
• Initial Report FDA Received Date: 11/03/2021
• Patient Sequence Number: 1