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

Model Number H12LP

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/30/2016

Event Type  malfunction  

Manufacturer Narrative

The device in question was returned for evaluation.The reprocessed ethicon h12lp was reprocessed one time by medline renewal.Upon receipt, we confirmed that the locking mechanism located on the adjustable fixation plug was broken.All other components met established inspection criteria.In addition, we performed a review of the device history record for lot number 302057.We reconfirmed that all processes were conducted as required and that the device met all the inspection requirements prior to packaging and release.Unfortunately, medline renewal does not have enough information to determine the root cause of the failure.Even though medline renewal confirmed that no adverse patient consequence, procedural delay, or medical intervention was required as a result of the device failure, in an abundance of caution medline renewal is filing this medwatch report.

Event Description

Medline renewal received a report indicating that the lock located on the adjustable fixation plug of a reprocessed ethicon xcel trocar, model h12lp broke while the scrub tech tried to lock it.Another device was readily available to complete the procedure, therefore there was no adverse patient consequence, procedural delay or medical intervention required.

• Brand Name: MEDLINE RENEWAL REPROCESSED ETHICON XCEL TROCAR
• Type of Device: LAPAROSCOPIC/ENDOSCOPIC TROCAR AND 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: 6088136
• MDR Text Key: 59466243
• Report Number: 3032391-2016-00013
• 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: health professional,user faci
• Reporter Occupation: Other
• 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: 05/31/2019
• Device Model Number: H12LP
• Device Catalogue Number: H12LP
• Device Lot Number: 302057
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2016
• 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