MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-28 for K012644 H12LP manufactured by Medline Renewal.
[112846966]
It was reported that the reprocessed ethicon h12lp trocar broke inside a patient during a procedure. Per report, the physician was able to locate the broken piece and successfully retrieve it from the patient. The reporting facility stated that they were able to grab another device and the surgery commenced without incident. There was no report of serious injury, adverse patient consequence or prolonged anesthesia related to the incident. The sample was not returned for evaluation. A root cause of the failure could not be determined at this time. Due to the reported incident and in an abundance of caution, renewal is filing this medwatch report. If additional relevant information becomes available, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[112846967]
It was reported that the reprocessed ethicon h12lp trocar broke inside a patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3032391-2018-00006 |
| MDR Report Key | 7646389 |
| Date Received | 2018-06-28 |
| Date of Report | 2018-06-28 |
| Date of Event | 2018-06-04 |
| Date Mfgr Received | 2018-06-08 |
| Device Manufacturer Date | 2018-04-12 |
| Date Added to Maude | 2018-06-28 |
| 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 | STEPHEN WILSON |
| Manufacturer Street | 1500 NE HEMLOCK AVE |
| Manufacturer City | REDMOND OR 97756 |
| Manufacturer Country | US |
| Manufacturer Postal | 97756 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Generic Name | ETHICON ENDOPATH? XCEL? BLUNT TIP TROCAR, W/SMOOTH SLEEVE & ADJUSTABLE PLUG |
| Product Code | NLM |
| Date Received | 2018-06-28 |
| Model Number | K012644 |
| Catalog Number | H12LP |
| Lot Number | 378574 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE RENEWAL |
| Manufacturer Address | 1500 NE HEMLOCK AVE REDMOND OR 97756 US 97756 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-06-28 |