MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-30 for NS-3600-B LITE GLOVE 1000/CASE 571711 manufactured by Covidien.
[49281126]
Submit date: 06/30/2016. An investigation is currently underway. Upon completion, the results will be forwarded. Attempts to gather information from the customer were made. To date, no response has been received. If additional pertinent information becomes available, the report will be updated.
Patient Sequence No: 1, Text Type: N, H10
[49281127]
It was reported to covidien on (b)(6) 2016 that a customer had an issue with a lite glove. The customer reports that the light handle glove is splitting during the procedure.
Patient Sequence No: 1, Text Type: D, B5
[56568051]
Submit date: 09/29/2016. The lot number was provided and the device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards. The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process. Because a sample was not returned, we were unable to perform a thorough follow up investigation to include functional and visual evaluations to confirm the reported issue and root cause analysis. A corrective and preventative action (capa) has been opened to determine the root cause of this reported event. When root cause(s) is determined the appropriate actions will be taken to address the reported condition. If additional information is received this complaint will be reopened. This complaint will be used for tracking and trending purposes.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612030-2016-00301 |
| MDR Report Key | 5761361 |
| Date Received | 2016-06-30 |
| Date of Report | 2016-06-24 |
| Date Mfgr Received | 2016-09-29 |
| Date Added to Maude | 2016-06-30 |
| 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 | EDWARD ALMEIDA |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524151 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | CALLE 9 SUR NO. 125 CUIDAD INDUSTRIAL |
| Manufacturer City | TULLAMORE 22500 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22500 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NS-3600-B LITE GLOVE 1000/CASE |
| Generic Name | LITE GLOVE |
| Product Code | LZC |
| Date Received | 2016-06-30 |
| Model Number | 571711 |
| Catalog Number | 571711 |
| Lot Number | 5341104364X |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | CALLE 9 SUR NO. 125 CUIDAD INDUSTRIAL TIJUANA MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-06-30 |