MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-11-22 for ENDO PADDLE RETRACT 173046 manufactured by Us Surgical Puerto Rico.
[167592718]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[167592719]
According to the reporter, pre-operatively, there were four devices, and each has ripped upon retracting into sheath. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
[184777196]
Evaluation summary: post market vigilance (pmv) led an evaluation of one device. A visual inspection of the returned product noted that the devices had damaged fabric paddle covers. Exposed deformation of the shafts of the introducers was observed. A functional evaluation found that the paddles were difficult to fully close due to the damage of both the shafts and paddle covers. 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 damaged paddle retractor cover may occur when either the paddle retractor is retracted with the paddle in a partially open state; pushing the introducer forward over a paddle that is not fully closed may cause stretching and breakage of the introducer; or if the paddle retractor is subjected to excessive manipulation or used for leverage, these forces may cause the tearing of the cover/ cloth. 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. 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
| Report Number | 2647580-2019-05732 |
| MDR Report Key | 9360480 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-11-22 |
| Date of Report | 2019-11-22 |
| Date Mfgr Received | 2019-11-05 |
| Date Added to Maude | 2019-11-22 |
| 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 PADDLE RETRACT |
| Generic Name | RETRACTOR |
| Product Code | GAD |
| Date Received | 2019-11-22 |
| Model Number | 173046 |
| Catalog Number | 173046 |
| Device Expiration Date | 1999-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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 | 2019-11-22 |