MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2016-11-08 for MEDLINE RENEWAL REPROCESSED ETHICON XCEL TROCAR H12LP manufactured by Medline Renewal.
[59557067]
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).
Patient Sequence No: 1, Text Type: N, H10
[59557068]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3032391-2016-00011 |
| MDR Report Key | 6088130 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-11-08 |
| Date of Report | 2016-11-08 |
| Date Mfgr Received | 2016-07-06 |
| Device Manufacturer Date | 2016-05-16 |
| Date Added to Maude | 2016-11-08 |
| 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, REPROCESSED |
| Product Code | NLM |
| Date Received | 2016-11-08 |
| Returned To Mfg | 2016-07-12 |
| Model Number | H12LP |
| Catalog Number | H12LP |
| Lot Number | 303905 |
| Device Expiration Date | 2019-05-31 |
| 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 | 2016-11-08 |