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 2018-03-07 for PURSTRING 020242 manufactured by Us Surgical Puerto Rico.
[101715557]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[101715558]
According to the reporter,during a total gastrectomy procedure, the surgeon clamped the tissue of the esophagus with purstring handle closed. While the surgeon was doing another handling, part of the ratchet burst and disengaged eventhough the surgeon did not touch any part of purstring device. A broken part fell into the cavity, and the surgeon retrieved it. As the jaws closed at that time, the surgeon thought the stapling was completed, then switched to the anastomosis, however, it was noted that the stapling was incomplete. Additional tissue resection was required due to the issue and there was tissue damage. The incision site was extended by more than 3 cm. The surgeon resected the tissue additionally and sutured it manually to complete the case. The surgical time was extended over 1 hour due to this event and the surgeon was enraged. Less than 200 cc of bleeding occurred as a result of the issue.
Patient Sequence No: 1, Text Type: D, B5
[109791031]
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. The handle lock was disengaged. 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 disengaged handle lock may occur when mishandled during clinical application. The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident. Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[109791032]
According to the reporter,during a total gastrectomy procedure, the surgeon clamped the tissue of the esophagus with purstring handle closed. While the surgeon was doing another handling, part of the ratchet burst and disengaged even though the surgeon did not touch any part of purstring device. The handle lock fell into the patient's cavity, and the surgeon retrieved it with the use of forceps. As the jaws closed at that time, the surgeon thought the stapling was completed, then switched to the anastomosis, however, it was noted that the stapling was incomplete. Additional tissue resection was required due to the issue and there was tissue damage. The incision site was extended by more than 3 cm. The surgeon resected the tissue additionally and sutured it manually to complete the case. The surgical time was extended over 1 hour due to this event and the surgeon was enraged. Less than 200 cc of bleeding occurred as a result of the issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2647580-2018-01200 |
| MDR Report Key | 7320103 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-03-07 |
| Date of Report | 2018-04-24 |
| Date of Event | 2018-02-13 |
| Date Mfgr Received | 2018-04-13 |
| Device Manufacturer Date | 2016-12-21 |
| Date Added to Maude | 2018-03-07 |
| 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 | 2018-03-07 |
| Returned To Mfg | 2018-03-16 |
| Model Number | 020242 |
| Catalog Number | 020242 |
| Lot Number | P6M0459X |
| 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 | 2018-03-07 |