MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENDOPATH** XCEL* DILATING TIP TROCAR WITH STABILITY SLEEVE; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Catalog Number D12LT

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/17/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The lot history records were reviewed and the manufacturing criteria were met prior to the release of this lot.

Event Description

It was reported that during a hysterectomy procedure, the device (dilating tip trocar) did not work properly when inserting it into cavity, that is, the blade shield was exposed and not retracted when inserting after the shield reset button was pressed.Another like device was used to complete the procedure.There were no adverse consequences for the patient.

Manufacturer Narrative

(b)(4).Batch # n9201h.The analysis results of the d12lt found that it was received with no damage in the external components.During the functional testing the bullet retracted permitting the exposure of the blade during the advancement through the skin test media and returned to safe position upon penetration; the bullet performed as intended without any anomalies noted.It could not be determined what may have caused the event reported.No conclusion could be reached as to what may have caused the reported incident.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.

• Type of Device: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo PR 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 00969
• Manufacturer Contact: milton garrett ; 4545 creek road ml 120a; cincinnati, OH 45242 ; 5133378865
• MDR Report Key: 6453954
• MDR Text Key: 71715833
• Report Number: 3005075853-2017-01789
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K032676
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: D12LT
• Device Lot Number: N4M840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1