MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-02-19 for GIA PREMIUM 030424L manufactured by Us Surgical Puerto Rico.
[100529272]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[100529273]
According to the reporter, intra-operatively, the staples did not deploy for the reload was empty, it was without staples. The surgeon used another reload for the end of the procedure. No patient injury.
Patient Sequence No: 1, Text Type: D, B5
[117598364]
Additional information: evaluation summary post market vigilance (pmv) led an evaluation of one device. The visual inspection of the returned product noted the reload displayed a full complement of staples. Damage was noted to the firing knob side of the knife blade channel. Microscopic inspection revealed no damage to the knife blade. Functional testing was precluded due to the observed condition of the device. A review of the device history record indicates the product was released meeting all quality release specifications at the time of manufacture. Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all medtronic quality release specifications at the time of manufacture. Replication of this condition may occur if an excessive force is applied to the knife blade assembly prior to firing. 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. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[117598365]
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2647580-2018-00830 |
| MDR Report Key | 7280732 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-02-19 |
| Date of Report | 2018-05-31 |
| Date of Event | 2018-02-02 |
| Date Mfgr Received | 2018-05-11 |
| Device Manufacturer Date | 2016-11-23 |
| Date Added to Maude | 2018-02-19 |
| 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 | GIA PREMIUM |
| Generic Name | APPARATUS, SUTURING, STOMACH AND INTESTINAL |
| Product Code | FHM |
| Date Received | 2018-02-19 |
| Returned To Mfg | 2018-02-16 |
| Model Number | 030424L |
| Catalog Number | 030424L |
| Lot Number | P6L0622X |
| 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 | 2018-02-19 |