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 2018-04-23 for B5LT manufactured by Medline Renewal.
[106194851]
It was reported that the clear plastic tip of a reprocessed ethicon b5lt 5mm trocar broke off as the surgeon was pulling the trocar out of the cannula, which was still in the patient's abdomen. The surgeon was able to locate the detached tip and retrieved it from the patient without further incident. There was no report of adverse patient consequence or prolonged anesthesia related to the incident. The sample was returned for evaluation and it was confirmed that the device was reprocessed. The complaint was confirmed however; a root cause could not be determined at this time. Due to the reported incident and in abundance of caution, this medwatch is being filed. If additional relevant information becomes available, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[106194852]
It was reported that the clear plastic tip of a reprocessed ethicon b5lt 5mm trocar broke.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3032391-2018-00003 |
| MDR Report Key | 7450333 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-04-23 |
| Date of Report | 2018-04-23 |
| Date of Event | 2018-03-29 |
| Date Mfgr Received | 2018-03-30 |
| Device Manufacturer Date | 2017-12-19 |
| Date Added to Maude | 2018-04-23 |
| 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 | 3 |
| Generic Name | ETHICON ENDOPATH? XCEL? BLADELESS TROCAR, W/STABILITY SLEEVE, 100MM LENGTH 5.0MM |
| Product Code | NLM |
| Date Received | 2018-04-23 |
| Returned To Mfg | 2018-04-13 |
| Catalog Number | B5LT |
| Lot Number | 369119 |
| Operator | PHYSICIAN |
| 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 | 2018-04-23 |