MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-18 for TRIEEA28MT manufactured by Us Surgical Puerto Rico.
[105875090]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[105875091]
According to the reporter: the patient underwent an laparoscopic sigmoidectomy procedure. The circular stapler was used during the last step of the surgery to create the anastomosis between the distal colon and rectum stump. There was poor staple formation. The handle was fully squeezed, there was no excessive tissue incorporated in the barrel, the instrument was not improperly matched, and the donuts were complete. The anvil could be tilted after firing, the anvil was not bent, and the stapler sizers were used. A leak test was performed using a coloscope and inter-operatively the staple line looked nice. An anastomotic leak occurred three days post operatively and required re-intervention. There was temporary injury as the leak needed to be fixed. There was tissue damage as the leak was over sewn. The event lead to or extended the patients hospitalization time by two days. There was no reported patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2647580-2018-01909 |
| MDR Report Key | 7441385 |
| Date Received | 2018-04-18 |
| Date of Report | 2018-04-18 |
| Date of Event | 2018-03-11 |
| Date Mfgr Received | 2018-04-03 |
| Date Added to Maude | 2018-04-18 |
| 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 | 0 |
| Generic Name | PLATE, BASE, SHELLAC |
| Product Code | EEA |
| Date Received | 2018-04-18 |
| Model Number | TRIEEA28MT |
| Catalog Number | TRIEEA28MT |
| Lot Number | V7M0963X |
| 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 | 1. Hospitalization; 2. Required No Informationntervention | 2018-04-18 |