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

Model Number	H12LP
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/20/2020
Type of Reportable Event	Malfunction
Additional 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.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.Additional information received: a photo was received for review.Upon visual inspection of the photo, the photo shows a totally dissembled trocar from front view.Based on the photo, the event described is confirmed.However, no conclusion or root cause could be determined as the device has not been received for analysis.Hands-on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.
Event or Problem Description
It was reported that during a laparoscopic bilateral inguinal hernia procedure, everything had gone well in the surgery until the doctor tried to introduce a gauze through the trocar.It was disassembled and the trocar cleaning membranes detached and fell into the patient.The trocar was disarmed.There were no patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Date sent: 6/30/2020.Investigation summary: the analysis results found that the h12lp device was returned with the seal damaged and torn.The torn piece of the seal was returned.The duckbill was returned out position and loose.The device was disassembled in order to evaluate the condition of the seal and the damage was confirmed.In addition, the separate piece of the seal 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.".

• Brand Name: ENDOPATH XCEL BLUNT TIP TROCAR
• Common Device Name: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 10099470
• Report Number: 3005075853-2020-02747
• Device Sequence Number: 16991020
• Product Code: GCJ
• UDI-Device Identifier: 10705036002017
• UDI-Public: 10705036002017
• 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,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2020

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 Expiration Date: 12/31/2024
• Device Model Number: H12LP
• Device Catalogue Number: H12LP
• Device Lot Number: U4009T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2020
• Initial Date Received by Manufacturer: 04/30/2020
• Supplement Date Received by Manufacturer: 06/11/2020
• Initial Report FDA Received Date: 05/28/2020
• Supplement Report FDA Received Date: 06/30/2020
• Patient Sequence Number: 1