MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. XCEL DILATING TIP TROCAR 11MM; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Catalog Number D11LT

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/04/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The lot/batch was not provided; therefore, the manufacturing records could not be reviewed.

Event Description

It was reported that during a laparoscopic cholecystectomy procedure, the surgeon claimed that the blade / shield did not advance forward once the trocar went through the abdominal wall.Surgeon then removed and repeated the same steps a few times but it still failed.He later asked the nurses to open another device and it works well.There was no patient consequence.

Manufacturer Narrative

(b)(4).Batch # r93m2v.The analysis results of the d11lt 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 reported complaint could not be confirmed.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.

• Brand Name: XCEL DILATING TIP TROCAR 11MM
• Type of Device: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8097321
• MDR Text Key: 128207255
• Report Number: 3005075853-2018-14555
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10705036001560
• UDI-Public: 10705036001560
• 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
• Report Date: 11/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: D11LT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: D11LT.; K11LT.