MAUDE Adverse Event Report: MEDLINE RENEWAL; ETHICON ENDOPATH® XCEL¿ BLUNT TIP TROCAR, W/SMOOTH SLEEVE & ADJUSTABLE PLUG

Catalog Number H12LPRH

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/01/2018

Event Type  malfunction  

Manufacturer Narrative

It was reported that a reprocessed ethicon h12lp fell apart during a laparoscopic cholecystectomy.Per report, the surgeon was able to locate and successfully retrieve all the broken pieces from the patient through an unknown method.The reporting facility stated that they were able to grab another device and the surgery commenced without further incident.There was no report of serious injury, adverse patient consequence or prolonged anesthesia related to the incident.The sample was not returned for evaluation.A root cause of the failure could not be determined at this time.Due to the reported incident and in an abundance of caution, renewal is filing this medwatch report.If additional relevant information becomes available, a supplemental medwatch will be filed.

Event Description

It was reported that a reprocessed ethicon h12lp fell apart into patient during laparoscopic cholecystectomy.

• Type of Device: ETHICON ENDOPATH® XCEL¿ BLUNT TIP TROCAR, W/SMOOTH SLEEVE & ADJUSTABLE PLUG
• 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: 7776814
• MDR Text Key: 117166936
• Report Number: 3032391-2018-00008
• 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,user f
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: H12LPRH
• Device Lot Number: 377933
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2018
• 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): Other; Required Intervention