MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2018-06-11 for ENDO GRASP 174233 manufactured by Us Surgical Puerto Rico.
[110614086]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[110614087]
According to the reporter, intraoperatively, when the device was pulled out, the jaw was cracked and broken. The balloon leaked gas or air.
Patient Sequence No: 1, Text Type: D, B5
[119541101]
Evaluation summary: post market vigilance (pmv) led an evaluation of one device. Shearing damage of the plastic cable sheath was observed. Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture. Analysis concluded there were no assembly component related failures. Replication of the reported condition may occur where an excessive force or leverage is applied to the device while retracting the clevis assembly and the clevis boot is subsequently damaged. This subsequent damage may result in improper retraction and deployment of the jaws during articulation and may cause shearing of the plastic cable sheath. The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2647580-2018-02800 |
| MDR Report Key | 7586938 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2018-06-11 |
| Date of Report | 2018-09-06 |
| Date of Event | 2018-05-04 |
| Date Mfgr Received | 2018-08-20 |
| Device Manufacturer Date | 2017-03-16 |
| Date Added to Maude | 2018-06-11 |
| 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 | 2018-06-11 |
| Returned To Mfg | 2018-07-09 |
| Model Number | 174233 |
| Catalog Number | 174233 |
| Lot Number | P7C0622X |
| 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 | 2018-06-11 |