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 2017-08-23 for GIA PREMIUM 030424L manufactured by Us Surgical Puerto Rico.
[83513363]
Manufacturer reference number: (b)(4). This event was originally reported on a quarterly summary report and is being resubmitted per fda request. Summary evaluation: post market vigilance (pmv) led an evaluation two device loading units and two photographs. The event report alleges the products were used in a surgical procedure. The loading units were received were fully fired with observed damage to the knife blade. The two photographs showed the staple line in the tissue. The staples were not properly formed. One staple was visually noted to have straight legs. A review of the device history record indicates the product was released meeting all quality release specifications at the time of manufacture. Replication of this condition may occur if the loading unit and knife blade was applied over an obstruction, which results in a damaged knife blade and improperly formed staples. The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident. No relationship between the device and the reported incident was confirmed. Based on the evidence available the reported condition was confirmed. 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
[83513364]
According to the reporter: occurred during an open hemicolectomy procedure. The stapling device was being used to divide the colon. There was poor staple formation. There was medical or surgical intervention needed to prevent a permanent impairment of a function. Extra sutures were put on the anastomosis. There was no unanticipated tissue loss or damage due to the product problem. The patient status is alive, no injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2647580-2017-06210 |
| MDR Report Key | 6813418 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-08-23 |
| Date of Report | 2017-03-27 |
| Date of Event | 2017-03-24 |
| Date Mfgr Received | 2017-03-27 |
| Device Manufacturer Date | 2016-07-20 |
| 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 | GIA PREMIUM |
| Generic Name | APPARATUS, SUTURING, STOMACH AND INTESTINAL |
| Product Code | FHM |
| Date Received | 2017-08-23 |
| Returned To Mfg | 2017-03-27 |
| Model Number | 030424L |
| Catalog Number | 030424L |
| Lot Number | P6G0482X |
| 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 | 2017-08-23 |