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

Model Number	TT012
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2022
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.An analysis of the product could not be performed since a physical sample was not received for evaluation.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 or additional information is received at a later date, the investigation will be updated as applicable.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 a respiratory surgery, the device was broken off.An endocameleon hopkins (karl storz) was used with the device and its bending part damaged the device.The surgeon commented that a broken part must have been discharged by suction.The customer reported that no pieces were left inside the patient.Another device was used to complete the case.There were no adverse consequences to the patient.The patient¿s condition is stable.
Additional Manufacturer Narrative
(b)(4).Date sent: 4/5/2022.Additional information was requested, and the following was obtained: does the surgeon believe a piece of the sleeve remains in the patient? or does the surgeon believe the broken part of tt012 device was removed by suction? there is a possibility that the broken piece was left in the patient but at the same time the surgeon had an opinion that the broken piece was discharged by suction.
Additional Manufacturer Narrative
(b)(4).Date sent: 5/18/2022.Additional information was requested and the following was received: can you confirm that the entire device has been accounted? no further information will be available.Can you confirm all parts were removed? => the customer reported that no pieces were left inside the patient.No further information will be available.Can you describe the size and shape of the piece that was broken off? no further information will be available.What type of instruments were exchanged through the trocar sleeve? no further information will be available.Were any sharp instruments exchanged through the trocar sleeve? no further information will be available.Are pictures of the device available? no.Was there any alleged deficiency of trocar sleeve? no further information will be available.Was any surgical intervention required? no.What is the current patient status? the patient¿s condition is stable.No further information will be available.

• Common Device Name: CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo ; 6107428552
• MDR Report Key: 13417528
• Report Number: 3005075853-2022-00611
• Device Sequence Number: 17111654
• Product Code: GEA
• UDI-Device Identifier: 10705036013372
• UDI-Public: 10705036013372
• Combination Product (Y/N): N
• PMA/510(K) Number: K920110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: TT012
• Device Catalogue Number: TT012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/05/2022
• Supplement Date Received by Manufacturer: 03/09/2022; 05/15/2022
• Initial Report FDA Received Date: 02/01/2022
• Supplement Report FDA Received Date: 04/05/2022; 05/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown