MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENDOPATH XCEL BLADELESS TROCAR; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Model Number B12SRT

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # unk.The lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.

Event Description

It was reported that during a laparoscopic colectomy, the valve was broken off 10 minutes after the beginning of use.The broken valve and forceps fell outside the patient.The device was used on the colon.No pieces fell into the patient.Another device was used to complete the case.There were no adverse consequences to the patient.

Manufacturer Narrative

(b)(4).Date sent: 2/11/2020.Investigation summary: the analysis results found that the b12srt device was received with the valve of stopcock damaged.No functional test was performed due the condition of the device.In addition, a piece of plastic was returned inside of a plastic bag.It is possible that the damaged valve was due to improper handling of the device.It should be noted that as part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.

Manufacturer Narrative

(b)(4).Date sent: 1/17/2020.H2: additional information: the device was received for evaluation, however evaluation not yet begun.

• Brand Name: ENDOPATH XCEL BLADELESS TROCAR
• Type of Device: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 9507128
• MDR Text Key: 202572620
• Report Number: 3005075853-2019-24696
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10705036001188
• UDI-Public: 10705036001188
• Combination Product (y/n): N
• PMA/PMN Number: K032676
• 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: 12/04/2019

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: B12SRT
• Device Catalogue Number: B12SRT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2020
• Initial Date Manufacturer Received: 12/04/2019
• Initial Date FDA Received: 12/20/2019
• Supplement Dates Manufacturer Received: 01/06/2020; 01/17/2020
• Supplement Dates FDA Received: 01/17/2020; 02/11/2020
• Patient Sequence Number: 1