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

Catalog Number	TB12LT
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown surgery, it was noted the device 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: 1/17/2024.D4: batch # unk.Additional information was requested and the following was obtained: "could you please provide more details to the complaint? which part of the device was damaged? was there any damage to the internal structure of the trocar? did the damage occurred during the procedure? if other, please specify -the tip of trocar was noted cracked.No piece dropped into the patient body." 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.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: BASX BLADELESS TROCAR 12MM
• Common Device Name: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 18528219
• Report Number: 3005075853-2024-00496
• Device Sequence Number: 18067324
• Product Code: GCJ
• UDI-Device Identifier: 10705036003007
• UDI-Public: 10705036003007
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K062209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/17/2024

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 Catalogue Number: TB12LT
• Device Lot Number: 137C10
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/25/2023
• Initial Report FDA Received Date: 01/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown