MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-17 for UNKNOWN ENDO ST manufactured by Davis & Geck Caribe Ltd.
[80301578]
Evaluation summary: post market vigilance (pmv) received one device. The visual inspection of the returned product noted that the casing was received with one needle with suture thread and one suture thread without needle. Under microscopic inspection of the needle marks on the edge of the loading slot. Pmv performed functional testing where the needles were loaded into the suturing device that they were returned with and applied to test media. Pressure was exerted on needle one in all directions from both sides of the jaws during this test in an effort to simulate clinical conditions; no pressure was exerted on needle two as suture thread did not have adequate length. The needles were found to function properly and remained engaged in the device throughout testing. No difficulty was experienced in loading, unloading, or toggling the needle.
Patient Sequence No: 1, Text Type: N, H10
[80301579]
According to the reporter: occurred during a laparoscopic roux-en-y procedure. The suturing device was being used for the jejunojejunostomy. The needle fell into the cavity of the patient and was retrieved using an atramatic device. The device was difficult to unload. In order to resolve the issue and complete the case, a new suturing device and needle reload were opened. There was no patient harm. The patient status is alive, no injury.
Patient Sequence No: 1, Text Type: D, B5
[117304897]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612501-2017-05786 |
| MDR Report Key | 6719255 |
| Date Received | 2017-07-17 |
| Date of Report | 2017-07-13 |
| Date of Event | 2017-05-12 |
| Date Mfgr Received | 2017-07-13 |
| Date Added to Maude | 2017-07-17 |
| 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 | SHARON MURPHY |
| Manufacturer Street | 60 MIDDLETOWN AVE |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal | 06473 |
| Manufacturer Phone | 2034925267 |
| Manufacturer G1 | DAVIS & GECK CARIBE LTD |
| Manufacturer Street | ZONA FRANCA DE SAN ISIDRO |
| Manufacturer City | SANTO DOMINGO 0101 |
| Manufacturer Country | DO |
| Manufacturer Postal Code | 0101 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Product Code | GDF |
| Date Received | 2017-07-17 |
| Returned To Mfg | 2017-05-26 |
| Model Number | UNKNOWN ENDO ST |
| Catalog Number | UNKNOWN ENDO ST |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DAVIS & GECK CARIBE LTD |
| Manufacturer Address | ZONA FRANCA DE SAN ISIDRO SANTO DOMINGO 0101 DO 0101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-17 |