MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-11-09 for MEDLINE RENEWAL REPROCESSED ETHICON XCEL TROCAR H12LP manufactured by Medline Renewal.
[59578436]
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).
Patient Sequence No: 1, Text Type: N, H10
[59578437]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3032391-2016-00025 |
| MDR Report Key | 6089361 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-11-09 |
| Date of Report | 2016-11-09 |
| Date of Event | 2016-08-29 |
| Date Mfgr Received | 2016-09-01 |
| Date Added to Maude | 2016-11-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. BRANDI PANTELEON |
| Manufacturer Street | 2747 SW 6TH ST. |
| Manufacturer City | REDMOND OR 97756 |
| Manufacturer Country | US |
| Manufacturer Postal | 97756 |
| Manufacturer Phone | 5415164180 |
| Manufacturer G1 | MEDLINE RENEWAL |
| Manufacturer Street | 2747 SW 6TH ST. |
| Manufacturer City | REDMOND OR 97756 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 97756 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDLINE RENEWAL REPROCESSED ETHICON XCEL TROCAR |
| Generic Name | LAPAROSCOPIC TROCAR |
| Product Code | NLM |
| Date Received | 2016-11-09 |
| Returned To Mfg | 2016-09-19 |
| Model Number | H12LP |
| Catalog Number | H12LP |
| Lot Number | UNKNOWN |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE RENEWAL |
| Manufacturer Address | 2747 SW 6TH ST. REDMOND OR 97756 US 97756 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-11-09 |