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 2017-08-26 for PURSTRING 020242 manufactured by Us Surgical Puerto Rico.
[83728425]
Patient Sequence No: 1, Text Type: N, H10
[83728426]
According to the reporter, during placing of the purstring on bowel in an open colon resection last (b)(6), the device did not fire correctly and had poor staple formation. They over sewed the staple line to fixed the issue. They hand sutured the purstring to resolve the issue in order to complete the case. There was no patient injury.
Patient Sequence No: 1, Text Type: D, B5
[118457926]
Evaluation summary: post market vigilance led an evaluation of one device. The visual inspection of the cartridges noted the instrument was fully applied. The instrument was received with pushers fully advanced; the cartridges were seated properly after firing. Visual and functional evaluation of the device found no abnormalities. Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture. Should new information become available, the file will be re-opened and the investigation summary amended as appropriate. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2647580-2017-06278 |
| MDR Report Key | 6823018 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-08-26 |
| Date of Report | 2017-12-16 |
| Date of Event | 2017-07-26 |
| Date Mfgr Received | 2017-11-17 |
| Date Added to Maude | 2017-08-26 |
| 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 AVENUE |
| 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 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 | 2017-08-26 |
| Returned To Mfg | 2017-08-09 |
| Model Number | 020242 |
| Catalog Number | 020242 |
| Lot Number | P7F1258X |
| 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 | 2017-08-26 |