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 2020-02-17 for HOL ML 5 MILLIMETER ENDO APPLIER 544965 manufactured by Teleflex Medical.
[184286425]
(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
[184286426]
It was reported that during an appendectomy, 544965 is used for loading and clipping, but the jaw is bent and cannot be used. Tried to remove the instrument later, but the jaw is bent, so cannot get it out of the 5mm trocar. Pulled with force and touched the side of the vessel, causing the vessel to tear. The procedure was changed from laparoscopic to open abdominal surgery and blood transfusions were carried out due to severe bleeding.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011137372-2020-00067 |
| MDR Report Key | 9717509 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2020-02-17 |
| Date of Report | 2020-02-06 |
| Date of Event | 2020-02-06 |
| Date Mfgr Received | 2020-03-17 |
| Date Added to Maude | 2020-02-17 |
| 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 | TELEFLEX MEDICAL |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27560 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HOL ML 5 MILLIMETER ENDO APPLIER |
| Generic Name | APPLIER, SURGICAL, CLIP |
| Product Code | GDO |
| Date Received | 2020-02-17 |
| Returned To Mfg | 2020-02-28 |
| Catalog Number | 544965 |
| Lot Number | 06M1526936 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | MORRISVILLE NC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2020-02-17 |