MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. XCEL DILATING TIP TROCAR 5MM; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Model Number	D5ST
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # r93x4l.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.Additional information received: a photo was received for review.Upon visual inspection of one photo, the following was observed: the photo shows a trocar device from top view inside of a plastic bag and no damage could be observed.Based on the photo reviewed, the event described cannot be confirmed.
Event or Problem Description
It was reported that during an unknown procedure, the shield reset button was non-functional when inserting through the "peritoneal." "patient was reported to be ok.".
Additional Manufacturer Narrative
(b)(4).Date sent: 3/4/2020.D4: batch # r93x4l.H10=corrected data=d10.D10: date device returned to manufacturer was actually 2/10/2020 and not 1/30/2020.Investigation summary: the analysis results found that the d5st device was returned with no damage in the external components.During 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.The event described could not be confirmed as the device performed without any difficulties noted.The reported complaint could not be confirmed.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances related to the reported complaint condition were identified.

• Brand Name: XCEL DILATING TIP TROCAR 5MM
• Common Device Name: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 9693979
• Report Number: 3005075853-2020-00925
• Device Sequence Number: 19536923
• Product Code: GCJ
• UDI-Device Identifier: 10705036001607
• UDI-Public: 10705036001607
• 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
• Report Date (Section B): 01/16/2020

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: 06/25/2023
• Device Model Number: D5ST
• Device Catalogue Number: D5ST
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2020
• Initial Date Received by Manufacturer: 01/16/2020
• Supplement Date Received by Manufacturer: 02/10/2020
• Initial Report FDA Received Date: 02/11/2020
• Supplement Report FDA Received Date: 03/04/2020
• Patient Sequence Number: 1