MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-11-08 for MEDLINE RENEWAL REPROCESSED ETHICON XCEL BLADELESSTROCAR B11LT manufactured by Medline Renewal.
[59558098]
The device in question was returned for evaluation, and it had been reprocessed one time by medline renewal. The b11lt cannula housing was broken and had detached from the sleeve component. There were no other defects or issues with the received device, and no information surrounding the incident was available at the time of investigation. In addition to the device investigation, we also performed a review of the device history record. We reconfirmed that all processes were conducted as required, and that the device met all the inspection requirements prior to packaging and release. During reprocessing, all devices are inspected and tested to validated acceptance criteria; therefore, the root cause of this device failure could not be determined at this time. Medline renewal performed a retrospective review of complaints and determined that this incident met the criteria for mdr reporting but was not filed within the required 30 day timeframe. Although no patient harm was reported, medical intervention was indicated as a result of the incident. Therefore medline renewal is retrospectively filing this medwatch report in an abundance of caution. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[59558099]
Medline renewal received a report that a reprocessed ethicon xcel bladeless trocar, model b11lt broke while being inserted into the patient. The report stated that staff had to open another trocar to complete the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3032391-2016-00018 |
| MDR Report Key | 6088143 |
| Report Source | USER FACILITY |
| Date Received | 2016-11-08 |
| Date of Report | 2016-11-08 |
| Date of Event | 2016-02-16 |
| Date Mfgr Received | 2016-03-14 |
| Device Manufacturer Date | 2015-08-28 |
| 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 |
| Reporter Occupation | SERVICE AND TESTING PERSONNEL |
| 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 BLADELESSTROCAR |
| Generic Name | LAPAROSCOPIC TROCAR/CANNULA |
| Product Code | NLM |
| Date Received | 2016-11-08 |
| Returned To Mfg | 2016-03-21 |
| Model Number | B11LT |
| Catalog Number | B11LT |
| Lot Number | 249808 |
| Device Expiration Date | 2018-08-30 |
| 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 |