MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-03-27 for HEMOLOK L CLIPS 3/CART 42/BOX 544243 manufactured by Teleflex Medical.
[185662446]
(b)(4). From the pictures attached was unable to be confirmed failure mode reported as clip reopens after locking. However, it is necessary to receive the physical sample to perform a proper investigation, determine root cause and implement corrective actions. A functional inspection of the product involved in the complaint could not be conducted since the product was not returned. P/n 544243 is not being manufactured currently, however, another part number from the same family was use for the verification of failure mode reported in the current manufacturing process and was conducted as follows: 13 samples were taken from the current production p/n 544240 hemolok l clips 6/cart 84/box, lot# 73b2000573, the samples were functionally inspected, and during the test issue reported clip reopens after locking was not observed in the current manufacturing process. Corrective actions cannot be established since it is necessary to receive the physical sample to perform a proper investigation and confirm the alleged defect. At this time due the sample is not available is not possible to determine the source of the defect reported. Teleflex will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10
[185662447]
It was reported that (b)(6) 2020, in (b)(6) hospital of hunan province, the clip was opened automatically after closure on the patient for removal of ovarian cyst and appendectomy; underwent laparoscopic and general anesthesia due to ovarian cyst and appendicitis. Then immediately took it out and replaced with a new one for ligating. No similar case occurred. There was no adverse effect on the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003898360-2020-00283 |
| MDR Report Key | 9889698 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-04 |
| Date of Event | 2020-03-02 |
| Date Mfgr Received | 2020-03-04 |
| Device Manufacturer Date | 2018-08-14 |
| Date Added to Maude | 2020-03-27 |
| 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 | TELEFLEX MEDICAL |
| Manufacturer Street | RANCHO EL DESCANSO |
| Manufacturer City | TECATE 21478 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 21478 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEMOLOK L CLIPS 3/CART 42/BOX |
| Generic Name | CLIP, IMPLANTABLE |
| Product Code | FZP |
| Date Received | 2020-03-27 |
| Catalog Number | 544243 |
| Lot Number | 73H1800271 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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. Required No Informationntervention | 2020-03-27 |