MAUDE Adverse Event Report: MEDLINE RENEWAL ETHICON; H12LP ENDPH XCEL BLUNT TIP TROCAR, W/SM

Catalog Number H12LPR

Device Problems Fracture (1260); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/18/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported that the plastic portion of the reprocessed ethicon endopath® xcel¿ blunt tip trocar, w/smooth sleeve & adjustable plug (purple) 12mm x 100mm, fractured during insufflation.Per report, the broken piece reached the surgical site and was successfully removed from the surgical site through an unidentified method.There was no report of a serious injury, an adverse patient consequence or prolonged anesthesia related to this incident.Due to the reported event and required medical intervention to retrieve the broken piece from the surgical site, this medwatch is being filed.The device was returned for evaluation and the complaint was confirmed.A review of the reprocessing records was performed and indicated that all processes were conducted as required.A definitive root cause could not be determined at this time.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.

Event Description

It was reported that during insufflation, the plastic portion of the reprocessed endopath® xcel¿ blunt tip trocar fractured and reached the surgical site.This was successfully retrieved through an unidentified method.

• Brand Name: ETHICON
• Type of Device: H12LP ENDPH XCEL BLUNT TIP TROCAR, W/SM
• Manufacturer (Section D): MEDLINE RENEWAL; 1500 ne hemlock ave; redmond OR 97756
• Manufacturer Contact: stephen wilson ; 1500 ne hemlock ave; redmond, OR 97756
• MDR Report Key: 8510438
• MDR Text Key: 145770985
• Report Number: 3032391-2019-00007
• Device Sequence Number: 1
• Product Code: NLM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: H12LPR
• Device Lot Number: 405492
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR