MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-12 for ETHICON H12LPR manufactured by Medline Renewal.
[145770985]
It was reported that the plastic portion of the reprocessed ethicon endopath? Xcel? Blunt tip trocar, w/smooth sleeve & adjustable plug (purple) 12mm x 100mm, fractured during insufflation. Per report, the broken piece reached the surgical site and was successfully removed from the surgical site through an unidentified method. There was no report of a serious injury, an adverse patient consequence or prolonged anesthesia related to this incident. Due to the reported event and required medical intervention to retrieve the broken piece from the surgical site, this medwatch is being filed. The device was returned for evaluation and the complaint was confirmed. A review of the reprocessing records was performed and indicated that all processes were conducted as required. A definitive root cause could not be determined at this time. No additional information is available. If additional information becomes available, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[145770986]
It was reported that during insufflation, the plastic portion of the reprocessed endopath? Xcel? Blunt tip trocar fractured and reached the surgical site. This was successfully retrieved through an unidentified method.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3032391-2019-00007 |
| MDR Report Key | 8510438 |
| Date Received | 2019-04-12 |
| Date of Report | 2019-04-12 |
| Date of Event | 2019-03-18 |
| Date Mfgr Received | 2019-03-22 |
| Device Manufacturer Date | 2018-11-30 |
| Date Added to Maude | 2019-04-12 |
| 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 |
| Brand Name | ETHICON |
| Generic Name | H12LP ENDPH XCEL BLUNT TIP TROCAR, W/SM |
| Product Code | NLM |
| Date Received | 2019-04-12 |
| Returned To Mfg | 2019-04-09 |
| Catalog Number | H12LPR |
| Lot Number | 405492 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-04-12 |