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

Model Number H12LP

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

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 that the suture stay located on the adjustable fixation plug was missing upon receipt.The device underwent a thorough inspection, and other than the missing suture stay, all other device components met established inspection criteria.In addition, we performed a review of the device history record for lot 303905, and we reconfirmed that all processes were conducted as required, and that the device met all the inspection requirements prior to initial packaging 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.However, in an abundance of caution, medline renewal is filing this report.(b)(4).

Event Description

Medline renewal received a report indicating that one of 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 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, REPROCESSED
• 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: 6088130
• MDR Text Key: 59557067
• Report Number: 3032391-2016-00011
• 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: Nurse
• 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: 303905
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2016
• 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