MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-20 for T-SEAL II 2METSEAL2 manufactured by Terumo Bct Europe N.v..
[63296047]
Investigation is in-process. A follow-up report will be provided.
Patient Sequence No: 1, Text Type: N, H10
[63296048]
The customer reported that while sealing tubing, there was a "flame" coming from the bottom of the sealer device. The device has been taken out of use. No patient or donor was present or connected at the time of the event, and the condition of the operator of the device is not known at this time. The patient (operator) information is not available at this time. Terumo bct (b)(4) is awaiting return of the device for evaluation.
Patient Sequence No: 1, Text Type: D, B5
[72831781]
The device was returned to terumo bct (b)(4) for evaluation. Upon visual inspection, wear was noted on the moving electrode with missing plating. Damage was also observed on the sealing rim and blood was noted on both the fixed and moving electrodes. It was also noted that the device had burn marks originating from the outside of the device. There was no indication of burns on the inside of the device. Twenty welds were performed with the device and the seals were normal. The device is functioning correctly. The manufacturing records were reviewed. No abnormalities were noted in the records that would have contributed to the issue. Root cause: the root cause of this failure is undetermined.
Patient Sequence No: 1, Text Type: N, H10
[78470627]
This report is being filed to provide additional information. Additional investigation: terumo bct leuven informed the customer with the evaluation results of the returned device. However, the customer declined repair and requested for the device to be returned to the customer's site. Terumo bct leuven initiated an internal capa for the reported condition.
Patient Sequence No: 1, Text Type: N, H10
[78470628]
Due to eu personal data protection laws, the patient (operator) information and outcome are not available from the customer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1722028-2016-00658 |
| MDR Report Key | 6191170 |
| Date Received | 2016-12-20 |
| Date of Report | 2016-12-20 |
| Date of Event | 2016-12-01 |
| Date Facility Aware | 2016-12-01 |
| Report Date | 2016-12-20 |
| Date Reported to Mfgr | 2016-12-20 |
| Date Mfgr Received | 2017-06-02 |
| Date Added to Maude | 2016-12-20 |
| 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 | STEVE KERN |
| Manufacturer Street | 10810 W. COLLINS AVE |
| Manufacturer City | LAKEWOOD CO 80215 |
| Manufacturer Country | US |
| Manufacturer Postal | 80215 |
| Manufacturer Phone | 3032392246 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | T-SEAL II |
| Generic Name | ME-TSEAL2 TUBE SEALING DEVICE 100-240V |
| Product Code | KSD |
| Date Received | 2016-12-20 |
| Model Number | 2METSEAL2 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TERUMO BCT EUROPE N.V. |
| Manufacturer Address | LEUVEN VLAAMS BRABANT BE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-12-20 |