MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2020-01-27 for EXTRACTION BAG FOR MIS IPN004942 332801-000020 manufactured by Teleflex Medical.
[181367002]
Qn#: (b)(4). The device has not been returned for investigation. Teleflex will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10
[181367003]
It was reported that the guidewire broke outside the patient when the bag was being removed through the trocar (ombilical). The bag fell opened back inside the abdomen with the extracted stomach piece. Clinical consequences: bag and contains retrieved. Further information indicates the break of the wire had no negative consequences for the patient. The surgeon removed the pieces in the abdomen. There was no damage. The trocar used was a 12mm one. The patient is fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006425876-2020-00104 |
| MDR Report Key | 9633676 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2020-01-27 |
| Date of Report | 2020-01-16 |
| Date of Event | 2020-01-14 |
| Date Mfgr Received | 2020-01-16 |
| Device Manufacturer Date | 2019-11-18 |
| Date Added to Maude | 2020-01-27 |
| 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 | EFFIE JEFFERSON |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194332672 |
| 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 | 3 |
| Brand Name | EXTRACTION BAG FOR MIS |
| Product Code | KGY |
| Date Received | 2020-01-27 |
| Model Number | IPN004942 |
| Catalog Number | 332801-000020 |
| Lot Number | 71F19L0610 |
| 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 | 2020-01-27 |