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

Model Number	CTB12LT
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4); batch #: unk.The lot/batch was not provided, therefore, a manufacturing record evaluation could not be performed.As the device was not returned, an analysis investigation could not be performed.A conclusion could not be reached as to what may have caused or contributed to the event.
Event or Problem Description
It was reported that during and unknown procedure, the trocar membrane released, and fell into the abdominal cavity.There was no delay to procedure, and membrane was removed from the abdominal cavity.Surgery was successfully completed.There was no patient consequence.
Additional Manufacturer Narrative
(b)(4).Date sent: 12/16/2020.H2: additional information received: please confirm if "membrane" means "seal".If not, please specify.Yes, seal were all the pieces recovered? were all parts recovered with the same procedure or was any additional procedure necessary or reoperation? all the pieces were recovered in the same procedure.Are the parts and the rest of the device sent for analysis? or was the membrane part discarded? they were not discarded by the customer.".

• Brand Name: BASX BLADELESS SLEEVE 12MM
• Common Device Name: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 11013739
• Report Number: 3005075853-2020-06827
• Device Sequence Number: 3813053
• Product Code: GCJ
• UDI-Device Identifier: 10705036001515
• UDI-Public: 10705036001515
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2020

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 Model Number: CTB12LT
• Device Catalogue Number: CTB12LT
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/24/2020
• Supplement Date Received by Manufacturer: 12/10/2020
• Initial Report FDA Received Date: 12/15/2020
• Supplement Report FDA Received Date: 12/16/2020
• Patient Sequence Number: 1