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

Catalog Number TT012

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # unk.A photo was received for review and upon visual inspection of the photo, the following was observed: the photo shows a black plastic piece on the hand of the user.Based on the photo alone, the event described could not be confirmed.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.A manufacturing record evaluation was performed for the finished device lot number and no non-conformances were identified.

Event Description

It was reported that during thoracoscopic lobectomy surgery, "after insert into the trocar," noted the fragment of the trocar in the patient and removed the fragment from patient.Another device was used to complete the surgery.There were no adverse consequences to the patient.No additional information could be provided.

• 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: kara ditty-bovard ; 475 calle c; guaynabo 00969 ; 6107428552
• MDR Report Key: 9485054
• MDR Text Key: 191731133
• Report Number: 3005075853-2019-24494
• Device Sequence Number: 1
• Product Code: GEA
• UDI-Device Identifier: 10705036013372
• UDI-Public: 10705036013372
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 11/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Catalogue Number: TT012
• Device Lot Number: T40G1E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1