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 2018-09-05 for ENDO GRASP 174233 manufactured by Us Surgical Puerto Rico.
[119334511]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[119334512]
According to the reporter, during laparoscopic cholecystectomy, when the device was opened and the activation was checked, the jaws could not open. A new product was opened and the procedure was performed. The event occurred during the procedure but the product was not used for patient.
Patient Sequence No: 1, Text Type: D, B5
[132626337]
Additional info: if information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[132626338]
Patient Sequence No: 1, Text Type: D, B5
[134608549]
Additional info: evaluation summary: post market vigilance (pmv) led an evaluation of one device. Visual inspection and functional testing carried out by engineering found that there were no abnormalities that would cause or contribute to the reported condition. Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture. The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[134608550]
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2647580-2018-04419 |
| MDR Report Key | 7847554 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-09-05 |
| Date of Report | 2019-01-31 |
| Date of Event | 2018-08-16 |
| Date Mfgr Received | 2019-01-09 |
| Device Manufacturer Date | 2016-11-04 |
| Date Added to Maude | 2018-09-05 |
| 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 | ENDO GRASP |
| Generic Name | MOTOR, SURGICAL INSTRUMENT, PNEUMATIC POWERED |
| Product Code | GET |
| Date Received | 2018-09-05 |
| Returned To Mfg | 2018-08-31 |
| Model Number | 174233 |
| Catalog Number | 174233 |
| Lot Number | P6L0090X |
| 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 | 2018-09-05 |