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

Catalog Number TT012

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem No Code Available (3191)

Event Date 07/05/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.The device history records were reviewed for all the possible lots reported and the manufacturing criteria were met prior to the release of the lots.Additional information was requested and the following was obtained: is the extended hospital stay because of the device breakage? no information from the hospital.And the re-operation was not planned.The patient was stable.The package was discarded.The following packaging lot# which may be used in this case: p4tc1g, r40060, r4032k, r4043a, r4054j, r40578, r4060l, r4080w, r40d14, r40f6z.Clarification is needed based on the additional information received.¿re-operation was not planned.¿ is this referring to the incision site that was re-opened during the initial surgery to retrieve the broken pieces from the patient to complete the procedure? no.""re-operation"" was referring to the re-operation after the initial procedure.Dr.Thought no pieces remained in the patient and re-operation was not planned.Was the hospital stay longer than what is expected for this type of surgery or did the patient follow the normal post-operative plan? no information for longer hospital stay.The sales rep reported the additional information; the patient was discharged.

Event Description

It was reported that during a laparoscopic and semi-open pneumonectomy, it was found that the device was broken off after closing the incision.Then, the incision site was reopened, and the broken pieces were all retrieved from the patient to complete the case.The incision site did not become bigger by re-opening.A little broken piece was not found, but it was confirmed that no more pieces were left inside the patient.Therefore, a re-operation will not be held.It was unknown when the device was broken off and the broken pieces fell off into the patient.No unexpected sound was heard during use.Competitive stapling device was used at the procedure.The surgeon commented about the contribution factors of this event as follows: it was possible that force was applied when the devices were used since the patient¿s intercostal space was narrow.It was also possible that the shaft of the competitive stapling device was bend though it was not removed from the sleeve fully, and it caused applying the force to the patient.The patient is still hospitalized, but the patient¿s condition is good.

Manufacturer Narrative

(b)(4).Serious injury updated to malfunction.Upon review of the information provided, it was concluded that this event does not meet the fda defined criteria for an adverse event (serious injury) and is being considered a malfunction.How was it confirmed that all pieces of the trocar were removed from the thoracic cavity? dr.Confirmed that all pieces of the trocar were removed because there was no piece in the thoracic cavity after searching the pieces.Was the post-operative care altered in anyway due to the issue with the trocar? no.Can you please confirm that this patient was only put under anesthesia one time? yes.

Manufacturer Narrative

(b)(4).Batch # unknown.Device analysis: the analysis results found that the tt012 instrument was received with the sleeve broken.One potential cause for the damage found may be the inadvertent application of excessive force or torquing during insertion into the abdominal cavity.The reported complaint was confirmed.We did not receive a batch or lot number for the product involved in this complaint.Therefore, we were unable to check manufacturing records for any related non-conformance's.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.How was it confirmed that all pieces of the trocar were removed from the thoracic cavity? was the post-operative care altered in anyway due to the issues with the trocar? can you please confirm that this patient was only put under anesthesia one time?.

• Type of Device: ENDOPATH THORACIC TROCAR
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 7735108
• MDR Text Key: 115592571
• Report Number: 3005075853-2018-11724
• Device Sequence Number: 1
• Product Code: GEA
• UDI-Device Identifier: 20705036013379
• UDI-Public: 20705036013379
• Combination Product (y/n): N
• PMA/PMN Number: K920110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/06/2018

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: TT012
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2018
• Initial Date Manufacturer Received: 07/06/2018
• Initial Date FDA Received: 07/31/2018
• Supplement Dates Manufacturer Received: 08/02/2018; 09/04/2018
• Supplement Dates FDA Received: 08/27/2018; 09/11/2018
• Patient Sequence Number: 1