MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENDOPATH*THORACIC TROCAR SLEEV; CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number TT012

Device Problems Crack (1135); Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/26/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch #: unknown.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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 Description

It was reported that during an unknown procedure, one of devices was broken off when a camera was removed through it.The procedure was thoracoscopic surgery for pulmonary malignant tumor.The tip of the sleeve was broken.The broken pieces was retrieved from the patient.Doctor thought the trocar may be broken when sandwiched between the camera and costa.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.

Manufacturer Narrative

(b)(4).Date sent: 12/21/2020.H2: additional information received: the procedure was thoracoscopic surgery for pulmonary malignant tumor.The tip of the sleeve was broken.The broken piece was retrieved from the patient.Doctor thought the trocar may be broken when was sandwiched between the camera and costa.

• Type of Device: CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 11016978
• MDR Text Key: 224833823
• Report Number: 3005075853-2020-06867
• Device Sequence Number: 1
• Product Code: GEA
• UDI-Device Identifier: 10705036013372
• UDI-Public: 10705036013372
• Combination Product (y/n): N
• PMA/PMN Number: K920110
• 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: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TT012
• Device Catalogue Number: TT012
• Device Lot Number: U40D94
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/01/2020
• Patient Sequence Number: 1