MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-26 for HOL ML 5 MILLIMETER ENDO APPLIER 544965 manufactured by Teleflex Medical.
[112458853]
(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
[112458854]
It was reported that while using a green hem-o-lok applier, during a prostatectomy, the applier broke when the doctor wanted to apply the 2nd clip. The 1st clip had been applied properly. There was no patient injury. Another applier was used to finish the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011137372-2018-00173 |
| MDR Report Key | 7638004 |
| Date Received | 2018-06-26 |
| Date of Report | 2018-06-04 |
| Date of Event | 2018-05-30 |
| Date Mfgr Received | 2018-08-16 |
| Date Added to Maude | 2018-06-26 |
| 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 | 0 |
| Brand Name | HOL ML 5 MILLIMETER ENDO APPLIER |
| Product Code | HBT |
| Date Received | 2018-06-26 |
| Returned To Mfg | 2018-06-21 |
| Catalog Number | 544965 |
| Lot Number | 06M1526940 |
| 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 | RESEARCH TRIANGLE PARK NC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-26 |