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

Model Number TT012

Device Problems Crack (1135); Use of Device Problem (1670)

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

Event Date 11/10/2022

Event Type  malfunction  

Event Description

It was reported that during a thoracoscopic lobectomy surgery, a part of the trocar broke during use.The broken piece has been retrieved.Another device was used to complete the case.There were no adverse consequences to the patient.

Manufacturer Narrative

(b)(4).Batch # unk.Additional information was requested and the following was obtained: "could you please specify what part of the trocar broke? no further information will be available.Was the sleeve broken? no further information will be available.Was the obturator broken? was the housing damaged? no further information will be available.Was there any insufflation issue? no further information will be available.Was there any seal damaged? if other please specify? no further information will be available.The procedure was thoracoscopic lobectomy.There was no change in the procedure when retrieving the broken piece from the patient.The patient was stable after the operation.The surgeon comment: i put too much force on the port.I broke it.The broken piece will be returned." investigation summary : the product was returned to ethicon for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample determined that the tt012 device was received with the tip of the sleeve broken.In addition, the piece of plastic from the sleeve was returned inside a petri dish.No conclusion could be reached regarding what may have caused the reported incident.One possible cause for the damage found may be due to excessive force being applied to the device.Please refer to the instructions for use for additional information regarding proper device usage.As part of ethicon¿s quality process, all devices are manufactured, inspected, and released to approved specifications.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.

Manufacturer Narrative

(b)(4).Date sent: 1/6/2023.This is an analysis of the photo submitted to ethicon for evaluation.During the visual analysis the following was observed: the tt012 with the tip of the sleeve broken.Based on the pi-16681832230813414 review, the event described sleeve issue confirmed, however, no conclusion or root cause could be determined.Please refer to the device analysis for full analysis details and conclusion.As part of the ethicon endo surgery quality process, all devices are manufactured, inspected, and released to approved specifications.The manufacturing records couldn't be reviewed as the batch number is unknown.

• Type of Device: 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 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 15986574
• MDR Text Key: 308137638
• Report Number: 3005075853-2022-08653
• Device Sequence Number: 1
• Product Code: GEA
• UDI-Device Identifier: 30705036013376
• UDI-Public: 10705036013372
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K920110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/06/2023

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
• Device Operator: Health Professional
• Device Model Number: TT012
• Device Catalogue Number: TT012
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 12/09/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/21/2022
• Initial Date FDA Received: 12/15/2022
• Supplement Dates Manufacturer Received: 12/19/2022
• Supplement Dates FDA Received: 01/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1