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 2017-11-22 for ENDO STITCH SULU UNKNOWN ENDO ST manufactured by Covidien North Haven-mfg.
[93249812]
Evaluation summary: post market vigilance (pmv) led an evaluation of three device. Device had bent blades. Device three was returned loaded with a needle that could not be unloaded from the device, needle was loaded upside down. Device one had bent blades. Device two had a broken needle piece lodged in the right jaw. Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture. Analysis concluded there were no assembly component related failures. Replication of the bent blade indicates that the instrument may have been exposed to an external force which bent the exposed metal bars. Replication of the improper loaded needle may occur if either the dlu or the endo stitch suturing device is held with the printed information facing down when the needle is loaded in the device. In this situation, marks will occur on the opposite side the loading slots of the needle. The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident. Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[93249813]
According to the reporter, prior to the procedure, the device jammed and it would not work. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219930-2017-09012 |
| MDR Report Key | 7053641 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-11-22 |
| Date of Report | 2017-11-22 |
| Date of Event | 2017-07-05 |
| Date Mfgr Received | 2017-10-27 |
| Date Added to Maude | 2017-11-22 |
| 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 | SHARON MURPHY |
| Manufacturer Street | 60 MIDDLETOWN AVE |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal | 06473 |
| Manufacturer Phone | 2034925267 |
| Manufacturer G1 | COVIDIEN NORTH HAVEN-MFG |
| Manufacturer Street | 195 MCDERMOTT RD |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06473 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDO STITCH SULU |
| Generic Name | TEST, LEUKOCYTE PEROXIDASE |
| Product Code | GIA |
| Date Received | 2017-11-22 |
| Returned To Mfg | 2017-08-03 |
| Model Number | UNKNOWN ENDO ST |
| Catalog Number | UNKNOWN ENDO ST |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN NORTH HAVEN-MFG |
| Manufacturer Address | 195 MCDERMOTT RD NORTH HAVEN CT 06473 US 06473 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-22 |