MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2017-08-23 for PREMIUM MULTIFIRE TA 010315- manufactured by Us Surgical Puerto Rico.
[83506460]
Patient Sequence No: 1, Text Type: N, H10
[83506461]
According to the reporter: occurred during a lung transplant. The stapler jammed after one use. The stapler cartridge would not remove from the device. The cartridge was not able to be removed or loaded into the handle. To resolve the issue, a new stapler was used. There was no patient injury. No medical intervention was required. Patient status is okay.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2647580-2017-06211 |
| MDR Report Key | 6813988 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-08-23 |
| Date of Report | 2017-04-03 |
| Date of Event | 2017-03-30 |
| Date Mfgr Received | 2017-04-03 |
| Date Added to Maude | 2017-08-23 |
| 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 | PREMIUM MULTIFIRE TA |
| Generic Name | APPARATUS, SUTURING, STOMACH AND INTESTINAL |
| Product Code | FHM |
| Date Received | 2017-08-23 |
| Model Number | 010315- |
| Catalog Number | 010315- |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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 | 2017-08-23 |