MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-06-22 for PURSTRING 020242 manufactured by Us Surgical Puerto Rico.
[112177762]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[112177763]
According to the reporter, during a low sigmoid resection, during air test after the creation of anastomosis in a open low sigmoid resection, they discovered a leak. As per surgeon and staff it seemed as if the purse string didn't catch all the tissue, creating a gap in the staple line. The surgeon used a suture to close the leak. There was no patient injury.
Patient Sequence No: 1, Text Type: D, B5
[119364334]
Evaluation summary: post market vigilance (pmv) led an evaluation of one device. The visual inspection of the returned product noted that the pushers are fully deployed. Cartridges are properly seated after firing. No visual abnormalities. Although the device was received with packaging the expiration date and lot number sticker were not received. The condition of the device precludes functional testing. 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 condition. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2647580-2018-03099 |
| MDR Report Key | 7630462 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-06-22 |
| Date of Report | 2018-09-05 |
| Date of Event | 2018-05-25 |
| Date Mfgr Received | 2018-08-17 |
| Date Added to Maude | 2018-06-22 |
| 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 | LISA HERNANDEZ |
| Manufacturer Street | 60 MIDDLETOWN AVE |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal | 06473 |
| Manufacturer Phone | 2034925563 |
| Manufacturer G1 | US SURGICAL PUERTO RICO |
| Manufacturer Street | 201 SABANETAS INDUSTRIAL PARK |
| Manufacturer City | PONCE PR 007164401 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 007164401 |
| 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 | 2018-06-22 |
| Returned To Mfg | 2018-06-20 |
| Model Number | 020242 |
| Catalog Number | 020242 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | US SURGICAL PUERTO RICO |
| Manufacturer Address | 201 SABANETAS INDUSTRIAL PARK PONCE PR 007164401 US 007164401 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-06-22 |