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 2018-09-26 for PURSTRING 020242 manufactured by Us Surgical Puerto Rico.
[121743870]
(b)(4). If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[121743871]
According to the reporter, during a low anterior resection / double stapling surgery, the surgeon started squeezing the handle of the device to stitch a rachet; however, the jaws broke. Broken pieces flew apart but were all retrieved. The part fell into the patient's cavity and was retrieved. The surgeon slightly resected intestinal canal of mouth side and used new device, then performed double stapling technique by circular stapler, and completed the procedure. The patient was in good condition on and after the low anterior resection / double stapling surgery. The surgical time was extended by less than 30 min.
Patient Sequence No: 1, Text Type: D, B5
[128083478]
Evaluation summary: post market vigilance (pmv) led an evaluation of one device. The visual inspection noted: that the device was broken in two pieces. Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture. Replication of the broken device may occur if the device is mishandled or handled roughly during application. The root cause of the observed damage was misuse of the product which caused or contributed to the reported condition. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2647580-2018-04705 |
| MDR Report Key | 7909904 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-09-26 |
| Date of Report | 2018-11-20 |
| Date of Event | 2018-09-05 |
| Date Mfgr Received | 2018-10-27 |
| Device Manufacturer Date | 2018-06-22 |
| Date Added to Maude | 2018-09-26 |
| 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 | 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 | 2018-09-26 |
| Returned To Mfg | 2018-09-12 |
| Model Number | 020242 |
| Catalog Number | 020242 |
| Lot Number | P8F1514X |
| 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 | 2018-09-26 |