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 2018-01-16 for PURSTRING 020242 manufactured by Us Surgical Puerto Rico.
[97521733]
Post market vigilance (pmv) led an evaluation of one device. The visual inspection of the returned product noted the instrument was received with the pushers fully deployed. The cartridges were observed to be properly seated after firing. One of the jaws was broken. No other visual abnormalities were observed. 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 failures. Replication of the observed condition can be produced by excessive mechanical force applied to the instrument on extreme tissue thickness. Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[97521734]
According to the reporter: occurred during a hartman's reversal procedure. During testing, the handle of the device broke. No patient injury has been noted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2647580-2018-00309 |
| MDR Report Key | 7194290 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-01-16 |
| Date of Report | 2018-01-16 |
| Date of Event | 2017-11-01 |
| Date Mfgr Received | 2017-12-20 |
| Device Manufacturer Date | 2015-10-28 |
| Date Added to Maude | 2018-01-16 |
| 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 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 | 2018-01-16 |
| Returned To Mfg | 2017-12-04 |
| Model Number | 020242 |
| Catalog Number | 020242 |
| Lot Number | P5K0790X |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2018-01-16 |