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 2020-02-05 for ENDO DISSECT 174213 manufactured by Us Surgical Puerto Rico.
[177936152]
Evaluation summary: post market vigilance (pmv) led an evaluation of one device. The visual inspection of the returned product noted that the plastic cable sheath had shearing damage. A functional evaluation found that jaw rotation worked without difficulty. Jaw opened and closed without difficulty, but articulation was difficult due to the damage to the device. Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture. 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 caused or contributed to the reported condition. The root cause of the observed damage was found to be due to the device not being used as intended which 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
[177936153]
According to the reporter, the plastic cover of the device was broken. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2647580-2020-00501 |
| MDR Report Key | 9674205 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-05 |
| Date of Report | 2020-02-05 |
| Date of Event | 2019-12-05 |
| Date Mfgr Received | 2019-12-05 |
| Device Manufacturer Date | 2017-04-07 |
| Date Added to Maude | 2020-02-05 |
| 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 |
| 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 DISSECT |
| Generic Name | MOTOR, SURGICAL INSTRUMENT, PNEUMATIC POWERED |
| Product Code | GET |
| Date Received | 2020-02-05 |
| Returned To Mfg | 2019-12-23 |
| Model Number | 174213 |
| Catalog Number | 174213 |
| Lot Number | P7D0175X |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2020-02-05 |