MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENDOPATH*THORACIC TROCAR SLEEV; ...

Model Number	TT012
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # unk.Investigation summary: the analysis results found that the tt012 instrument was received with the sleeve broken.Due to the damage found on the device, a possible cause for this condition is due to improper handling during transit or storage.It should be noted that as part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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 by that during a respiratory surgery, the trocar sleeve of the device broke.The broken pieces were retrieved.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.

• Common Device Name: ...
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• MDR Report Key: 10434760
• Report Number: 3005075853-2020-04244
• Device Sequence Number: 2343973
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2024
• Device Model Number: TT012
• Device Catalogue Number: TT012
• Device Lot Number: T4101N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/27/2020
• Initial Report FDA Received Date: 08/20/2020
• Patient Sequence Number: 1