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

Model Number K012644

Device Problem Break (1069)

Patient Problems Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)

Event Date 06/04/2018

Event Type  malfunction  

Manufacturer Narrative

It was reported that the reprocessed ethicon h12lp trocar broke inside a patient during a procedure.Per report, the physician was able to locate the broken piece and successfully retrieve it from the patient.The reporting facility stated that they were able to grab another device and the surgery commenced without 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 the reprocessed ethicon h12lp trocar broke inside a patient.

• 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: 7646389
• MDR Text Key: 112846966
• Report Number: 3032391-2018-00006
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/28/2018

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
• Device Operator: Physician
• Device Expiration Date: 04/30/2021
• Device Model Number: K012644
• Device Catalogue Number: H12LP
• Device Lot Number: 378574
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/08/2018
• Initial Date FDA Received: 06/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention