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

Model Number H12LP

Device Problems Fracture (1260); Material Integrity Problem (2978)

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

Event Date 08/29/2016

Event Type  malfunction  

Manufacturer Narrative

The device was returned to medline renewal for evaluation.We confirmed that the trocar in question was reprocessed one time, and we confirmed the suture stays located on the adjustable fixation plug were broken upon receipt.The device went through a thorough inspection and other than the suture stays that broke off the device, all other device components met established inspection criteria prior to initial package and release unfortunately, medline renewal does not have enough information to determine the actual root cause of the failure.Medline renewal confirmed that no adverse patient consequence, procedural delay, or medical intervention was required as a result of the device failure.Therefore in an abundance of caution, medline renewal is filing this medwatch report.(b)(4).

Event Description

Medline renewal received a report indicating that the suture stays located on the adjustable fixation plug of a reprocessed ethicon xcel trocar, model h12lp, detached during use.The component is used to secure suture during the course of the surgery.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 TROCAR
• 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: 6089361
• MDR Text Key: 59578436
• Report Number: 3032391-2016-00025
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: H12LP
• Device Catalogue Number: H12LP
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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