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

Model Number	CTB5LT
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # unk.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Attempts are being made to retrieve the device.To date, no additional information has been received and no device has 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 appendectomy procedure, a 5 mm basx trocar was broken at the time it was introduced into the patient.Though surgery was delayed by five minutes, another trocar was used and the procedure was successfully completed.There were no fragment and there was no patient consequence.

• Brand Name: BASX BLADELESS SLEEVE 5MM
• Common Device Name: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• MDR Report Key: 11252107
• Report Number: 3005075853-2021-00525
• Device Sequence Number: 2551865
• Product Code: GCJ
• UDI-Device Identifier: 10705036001522
• UDI-Public: 10705036001522
• Combination Product (Y/N): N
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/17/2021

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: 08/31/2024
• Device Model Number: CTB5LT
• Device Catalogue Number: CTB5LT
• Device Lot Number: T40U8D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/17/2021
• Initial Report FDA Received Date: 01/29/2021
• Patient Sequence Number: 1