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 2018-10-16 for ENDO GRASP 173030 manufactured by Us Surgical Puerto Rico.
[123831519]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[123831520]
According to the reporter, when grasping lobe of a lung during a laparoscopic lobectomy, the grasper fell apart. The handles were binding while clamped on tissue. The surgeon had been grasping tissue before this with no difficulty. They pulled another grasper and continued with the procedure. There was no patient injury.
Patient Sequence No: 1, Text Type: D, B5
[134868185]
Additional info: evaluation summary: post market vigilance (pmv) led an evaluation of one device. Handle of device had broken at pivot\attachment point. Both covers of the handles were broken. A review of the device history record indicates this product was released meeting all quality release specifications at the time of manufacture. Replication of the reported condition may occur when the device is activated (handles contracted) with excessive force and\or used for leveraging; these actions would cause the handle lever to detach and break open the cover of the handle body. The root cause of the observed damage was misuse of the product which caused or contributed to the reported condition. No further actions have been deemed necessary at this time. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[134868186]
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2647580-2018-04993 |
| MDR Report Key | 7969354 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-10-16 |
| Date of Report | 2019-02-01 |
| Date of Event | 2018-09-20 |
| Date Mfgr Received | 2019-01-10 |
| Device Manufacturer Date | 2017-08-24 |
| Date Added to Maude | 2018-10-16 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | FORCEPS, OBSTETRICAL |
| Product Code | HDA |
| Date Received | 2018-10-16 |
| Returned To Mfg | 2018-10-18 |
| Model Number | 173030 |
| Catalog Number | 173030 |
| Lot Number | P7H1803PX |
| 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 | 2018-10-16 |