MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-10 for EXTRACTION BAG FOR MIS 332800-000010 manufactured by Teleflex Medical.
[79750565]
(b)(4). The facility has communicated that the device is not available for evaluation. Teleflex will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10
[79750566]
During a cholecystectomy under coelioscopy the pusher of the bag broke at the base during its removal without any excessive action. The bag was removed with a catching medical applier. The surgeon removed all broken pieces of the pusher from the patient. Surgery time was increased. Another bag was used. There was no patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006425876-2017-00215 |
| MDR Report Key | 6698627 |
| Date Received | 2017-07-10 |
| Date of Report | 2017-06-22 |
| Date of Event | 2017-06-19 |
| Date Mfgr Received | 2017-08-02 |
| Device Manufacturer Date | 2017-04-26 |
| Date Added to Maude | 2017-07-10 |
| 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 | JASMINE BROWN |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9193614124 |
| Manufacturer G1 | ARROW INTERNATIONAL CR, A.S. |
| Manufacturer Street | JAMSKA 2359/47 |
| Manufacturer City | ZDAR NAD SAZAVOU 591 01 |
| Manufacturer Country | EZ |
| Manufacturer Postal Code | 591 01 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | EXTRACTION BAG FOR MIS |
| Product Code | KGY |
| Date Received | 2017-07-10 |
| Catalog Number | 332800-000010 |
| Lot Number | 71F17D1099 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | ATHLONE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-10 |