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 2017-12-05 for PURSTRING 020730 manufactured by Us Surgical Puerto Rico.
[93820467]
To date, the incident sample has not been received for evaluation. If the sample is received, or if additional information pertinent to the incident is obtained, a follow-up report will be submitted. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[93820468]
According to the reporter, during a total gastrectomy/r-y procedure, the surgeon set the device on the tissue and tried to squeeze the ring handles for locking, however the shaft was broken. The procedure was completed with another device. No noted problem to patient status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2647580-2017-08324 |
| MDR Report Key | 7083627 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-12-05 |
| Date of Report | 2017-12-05 |
| Date of Event | 2017-11-17 |
| Date Mfgr Received | 2017-11-21 |
| Date Added to Maude | 2017-12-05 |
| 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 | US SURGICAL PUERTO RICO |
| Manufacturer Street | 201 SABANETAS INDUSTRIAL PARK |
| Manufacturer City | PONCE 00716-440 |
| Manufacturer Postal Code | 00716-4401 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PURSTRING |
| Generic Name | CLAMP, SURGICAL, GENERAL & PLASTIC SURGERY |
| Product Code | GDJ |
| Date Received | 2017-12-05 |
| Model Number | 020730 |
| Catalog Number | 020730 |
| Device Expiration Date | 1999-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | US SURGICAL PUERTO RICO |
| Manufacturer Address | 201 SABANETAS INDUSTRIAL PARK PONCE 00716-440 00716-4401 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-05 |