MAUDE Adverse Event Report: MEDLINE RENEWAL MEDLINE RENEWAL REPROCESSED ETHICON XCEL BLADELESSTROCAR; LAPAROSCOPIC TROCAR/CANNULA

Model Number B11LT

Device Problems Break (1069); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/16/2016

Event Type  malfunction  

Manufacturer Narrative

The device in question was returned for evaluation, and it had been reprocessed one time by medline renewal.The b11lt cannula housing was broken and had detached from the sleeve component.There were no other defects or issues with the received device, and no information surrounding the incident was available at the time of investigation.In addition to the device investigation, we also performed a review of the device history record.We reconfirmed that all processes were conducted as required, and that the device met all the inspection requirements prior to packaging and release.During reprocessing, all devices are inspected and tested to validated acceptance criteria; therefore, the root cause of this device failure could not be determined at this time.Medline renewal performed a retrospective review of complaints and determined that this incident met the criteria for mdr reporting but was not filed within the required 30 day timeframe.Although no patient harm was reported, medical intervention was indicated as a result of the incident.Therefore medline renewal is retrospectively filing this medwatch report in an abundance of caution.(b)(4).

Event Description

Medline renewal received a report that a reprocessed ethicon xcel bladeless trocar, model b11lt broke while being inserted into the patient.The report stated that staff had to open another trocar to complete the procedure.

• Brand Name: MEDLINE RENEWAL REPROCESSED ETHICON XCEL BLADELESSTROCAR
• Type of Device: LAPAROSCOPIC TROCAR/CANNULA
• Manufacturer (Section D): MEDLINE RENEWAL; 2747 sw 6th st.; redmond OR 97756
• Manufacturer (Section G): MEDLINE RENEWAL; 2747 sw 6th st.; redmond OR 97756
• Manufacturer Contact: brandi panteleon ; 2747 sw 6th st.; redmond, OR 97756 ; 5415164180
• MDR Report Key: 6088143
• MDR Text Key: 59558098
• Report Number: 3032391-2016-00018
• Device Sequence Number: 1
• Product Code: NLM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K012644
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Service and Testing Personnel
• Type of Report: Initial
• Report Date: 11/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/30/2018
• Device Model Number: B11LT
• Device Catalogue Number: B11LT
• Device Lot Number: 249808
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention