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

Model Number	B5ST
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch #unk.Attempts are being made to obtain the device.To date, no device has been received.If the device is received at a later date, a supplemental medwatch will be sent.The lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed.
Event or Problem Description
It was reported that during an unknown procedure, the device broke.The broken pieces were retrieved, but the customer requested the investigation to reveal all the broken pieces were retrieved just in case some pieces fell inside the patient.Small black pieces are rubber gasket from inside the trocar sleeve and are not hard plastic from outside of the device.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.
Additional Manufacturer Narrative
(b)(4).Date sent: 2/13/2020.Investigation summary: the analysis results found that the b5st device was returned with the duckbill damaged and torn.The torn piece of the duckbill was returned inside a plastic jar.The device was disassembled in order to evaluate the condition of the duckbill and the damage was confirmed.In addition, the separate piece of the duckbill was observed to have a mark, which suggests that a pointy instrument was inserted through the trocar with excessive force.Per instructions for use: "use caution when introducing or removing instruments through the trocar sleeve in order to prevent inadvertent damage to the seals which could result in loss of pneumoperitoneum.Special care should be used when inserting sharp or angled edged endoscopic instruments to prevent tearing the seal." in addition, a photo was received.The photo shows a trocar device from top view and no anomalies could be observed.Based on the photo alone, the event described could not be confirmed.
Additional Manufacturer Narrative
(b)(4).Date sent: 1/22/2020.D4: batch # unk.H2: additional information received: can you please clarify if the small black piece is a rubber gasket from inside of the trocar sleeve? yes.Or is the piece a hard plastic piece from the outside of the device? no.In addition, a photo was received for review and the photos shows a trocar device from top view and no anomalies could be observed.Based on the photo alone, the event describe cannot be confirmed.

• Brand Name: ENDOPATH XCEL BLADELESS TROCAR
• Common Device Name: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 9594075
• Report Number: 3005075853-2020-00337
• Device Sequence Number: 361712
• Product Code: GCJ
• UDI-Device Identifier: 10705036001232
• UDI-Public: 10705036001232
• Combination Product (Y/N): N
• PMA/510(K) Number: K032676
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/20/2019

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
• Operator of Device: Health Professional
• Device Model Number: B5ST
• Device Catalogue Number: B5ST
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2020
• Initial Date Received by Manufacturer: 12/20/2019
• Supplement Date Received by Manufacturer: 01/22/2020; 01/22/2020
• Initial Report FDA Received Date: 01/15/2020
• Supplement Report FDA Received Date: 01/22/2020; 02/13/2020
• Patient Sequence Number: 1