MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-24 for 3632 LITE SLEEVE 31140240 manufactured by Covidien.
[29830609]
Submit date: 10/22/2015. An investigation is currently underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
[29830610]
It was reported to covidien on (b)(6) 2015 that a customer had an issue with a lite sleeve. The customer states that during a surgery, the lite sleeve slipped from the lite handle and fell into the op area. After testing the situation, it was noticed that the user pulled the lite sleeve over a reusable lite handle without a covidien adapter on the lamp. The customer further reports no person injured. An approved adapter is required for all of our disposable light handle products and it was reported that the user did not use a covidien adapter with the disposable lite sleeve in this incident.
Patient Sequence No: 1, Text Type: D, B5
[48720804]
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. The complaint will be re-opened if a sample is received. During the assembly process there is no a condition that could affect the product in the reported way. The potential root cause is due to misuse of the product. Based on information received from the customer, a covidien adapter was not used with the disposable lite sleeve. An approved adapter is required for all of our disposable lite handle products. In this case, it was reported that the user did not use a covidien adapter with the disposable lite sleeve. As the reported issue did not occur during the manufacturing process a root cause was not identified and a corrective action will be limited to the manufacturing awareness. The current process is running according to product specifications meeting quality acceptance criteria. A production notification was performed to all personnel to ensure that they are aware on the condition reported by the customer. If additional information is received warranting further analysis, the investigation will be resumed. This complaint will be used for tracking and trending purposes.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612030-2015-00102 |
| MDR Report Key | 5173101 |
| Date Received | 2015-10-24 |
| Date of Report | 2015-10-15 |
| Date of Event | 2015-10-15 |
| Date Mfgr Received | 2016-07-05 |
| Device Manufacturer Date | 2015-04-20 |
| Date Added to Maude | 2015-10-24 |
| 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 | THOM MCNAMARA |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524811 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | CALLE 9 SUR NO. 125 CUIDAD INDUSTRIAL |
| Manufacturer City | TIJUANA |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3632 LITE SLEEVE |
| Generic Name | LITE SLEEVE |
| Product Code | FQP |
| Date Received | 2015-10-24 |
| Model Number | 31140240 |
| Catalog Number | 31140240 |
| Lot Number | 5103105264X |
| 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 | 2015-10-24 |