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

Model Number TT012

Device Problem Crack (1135)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/07/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch # unk.Additional information received: where was the tt012 trocar placed? midaxillary puncture at the 7th intercostal position what instruments were being used through the tt012 port? olympus hd laparoscope was there any torquing or excessive pressure on the instruments that were through the trocar port? mirror rod body has torque and pressure.Was the trocar port completely inserted or partially inserted when manipulating the instruments that were in these trocars? completely inserted.Were any energy/cautery devices used near the tip of the trocar? no.At what point was the trocar broken (did breakage occur at insertion or during procedure when instruments were in the trocar)? after the instrument was removed, the casing was pulled out.Were any scans done or were any attempts made to find the missing trocar piece? no was there any alteration of the post-op care of the patient due to the difficulties experienced with the trocar? no.Was the tt012 device discarded or is the trocar available to send back for analysis? the cannula has been discarded during the operation in patient with hepatitis b.In addition, two photos were received for review.Upon visual inspection of two photos, the following was observed: the photos show a trocar of 12mm from top view and the sleeve can be seen damaged.Based on the photos reviewed, the event described is confirmed, however no conclusion or root cause could be determined as device was not returned and an analysis investigation could not be performed.A conclusion could not be reached as to what may have caused or contributed to the event.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that during the endoscopic resection of cardiac cancer, tt012 trocar was damaged.Changed to another device to complete the procedure.The trocar sleeve was broken into a few pieces and other pieces were taken out of patient, but there was one piece that still could not be found in the patient's body.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 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo 00969 ; * 00969 ; 6107428552
• MDR Report Key: 10348318
• MDR Text Key: 201562289
• Report Number: 3005075853-2020-03916
• 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: 07/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TT012
• Device Catalogue Number: TT012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/07/2020
• Initial Date FDA Received: 07/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other