MAUDE Adverse Event Report: MEDLINE RENEWAL; ETHICON ENDOPATH® XCEL¿ BLADELESS TROCAR, W/STABILITY SLEEVE, 100MM LENGTH 5.0MM

Catalog Number	B5LT
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the clear plastic tip of a reprocessed ethicon b5lt 5mm trocar broke off as the surgeon was pulling the trocar out of the cannula, which was still in the patient's abdomen.The surgeon was able to locate the detached tip and retrieved it from the patient without further incident.There was no report of adverse patient consequence or prolonged anesthesia related to the incident.The sample was returned for evaluation and it was confirmed that the device was reprocessed.The complaint was confirmed however; a root cause could not be determined at this time.Due to the reported incident and in abundance of caution, this medwatch is being filed.If additional relevant information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the clear plastic tip of a reprocessed ethicon b5lt 5mm trocar broke.

• Common Device Name: ETHICON ENDOPATH® XCEL¿ BLADELESS TROCAR, W/STABILITY SLEEVE, 100MM LENGTH 5.0MM
• Manufacturer (Section D): MEDLINE RENEWAL; 1500 ne hemlock ave; redmond OR 97756
• MDR Report Key: 7450333
• Report Number: 3032391-2018-00003
• Device Sequence Number: 1642739
• Product Code: NLM
• UDI-Device Identifier: 10888277381070
• UDI-Public: 10888277381070
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: B5LT
• Device Lot Number: 369119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/30/2018
• Initial Report FDA Received Date: 04/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention