MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-07 for ENDO GRASP* 5MM INSTRUMENT 173030 manufactured by Covidien, Formerly Ussc Puerto Rico Inc.
[27940661]
(b)(4). Additional attempts to obtain information and the device have been made. A supplemental report will be submitted with new details if they become available.
Patient Sequence No: 1, Text Type: N, H10
[27940662]
According to the reporter, during a hiatal hernia procedure, one of the two grasping jaws broke. Physician informs that this happened meanwhile he was knotting a stitch so at that moment he was not making any unusual pressure or traction on the endograsp. The piece fell in patient's cavity and was recovered with a little bit of difficulty but with no issues for patient. Patient status is correct.
Patient Sequence No: 1, Text Type: D, B5
[31102674]
Patient Sequence No: 1, Text Type: N, H10
[31102675]
According to the reporter, no, patient data was available. There was difficulty to find the small broken jaw falling in the patient cavity. The surgeon said to me it take more or less 20 minutes to find the broken jaw and to take it away. There was no tissue loss or damage. There was no blood loss or extension of or time past 30 minutes. .
Patient Sequence No: 1, Text Type: D, B5
[32600970]
Evaluation summary: post market vigilance (pmv) led an evaluation of one device opened by the account. This evaluation was based on a technical review of all data received from the site, a pmv review of manufacturing records, a pmv review of complaint trends, and an evaluation of the returned device. The device was received with the jaw detached from the instrument. Functional testing could not be performed due to the noted damage. A review of the device history record indicates this device lot number was released meeting all quality release specifications at the time of manufacture. Engineering concluded that replication of the reported condition can be related to excessive manipulation during the application that consequently caused the breakage of the jaw. The unit is consistent with a unit that was manipulated with excessive force during procedure. There were no adverse patient events reported as a result of the alleged event. Should new information become available, the file will be re-opened and reassessed at that time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2647580-2015-00711 |
| MDR Report Key | 5131421 |
| Date Received | 2015-10-07 |
| Date of Report | 2015-12-02 |
| Date of Event | 2015-09-25 |
| Date Mfgr Received | 2015-12-02 |
| Device Manufacturer Date | 2015-01-01 |
| Date Added to Maude | 2015-10-07 |
| 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 AVE |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal | 06473 |
| Manufacturer Phone | 2034925267 |
| Manufacturer G1 | COVIDIEN, FORMERLY USSC PUERTO RICO INC |
| Manufacturer Street | BUILDING 911-67 SABANETAS INDUSTRIAL PARK |
| Manufacturer City | PONCE PR 00731 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00731 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDO GRASP* 5MM INSTRUMENT |
| Generic Name | FORCEPS, OBSTETRICAL |
| Product Code | HAD |
| Date Received | 2015-10-07 |
| Returned To Mfg | 2015-10-22 |
| Model Number | 173030 |
| Catalog Number | 173030 |
| Lot Number | P5A0473X |
| ID Number | 20884523000754 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN, FORMERLY USSC PUERTO RICO INC |
| Manufacturer Address | BUILDING 911-67 SABANETAS INDUSTRIAL PARK PONCE PR 00731 US 00731 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-10-07 |