MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-02-10 for ENDO STITCH 173016 manufactured by Davis & Geck Caribe Ltd.
[179430565]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[179430566]
According to the reporter, during a laparoscopic gastric bypass, the needle got stuck in the instrument. The instrument was not attached to any part of the patient when this happened. The surgeon removed the instrument from the patient and attempted to manually remove the suture. At this time, the needle broke. Portion of the needle still attached to instrument.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612501-2020-00247 |
| MDR Report Key | 9690989 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-02-10 |
| Date of Report | 2020-02-10 |
| Date of Event | 2020-01-01 |
| Date Mfgr Received | 2020-01-28 |
| Date Added to Maude | 2020-02-10 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LISA HERNANDEZ |
| Manufacturer Street | 60 MIDDLETOWN AVE. |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal | 06473 |
| Manufacturer Phone | 2034925563 |
| Manufacturer G1 | DAVIS & GECK CARIBE LTD |
| Manufacturer Street | ZONA FRANCA DE SAN ISIDRO |
| Manufacturer City | SANTO DOMINGO 18750 |
| Manufacturer Country | DO |
| Manufacturer Postal Code | 18750 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDO STITCH |
| Generic Name | ENDOSCOPIC TISSUE APPROXIMATION DEVICE |
| Product Code | OCW |
| Date Received | 2020-02-10 |
| Model Number | 173016 |
| Catalog Number | 173016 |
| Lot Number | J9H18535Y |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 18750 DO 18750 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-10 |