MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2017-11-08 for SADDLELOOP 18G X 10CM WITH BLUNT NEEDLE 1541 manufactured by Quest Medical, Inc..
[92606340]
This issue occurred outside of the us. Similar devices manufactured by quest medical are currently sold in the us. There were no patient complications resulting from this issue. Examination of the returned device confirmed the alleged complaint. The tensioner was off of the tape. Visual examination of the device under black light found insufficient adhesive on the device. Adhesive is required to hold the tensioner on the device. A corrective action has been implemented for this issue to ensure the right amount of glue is dispensed to keep the tensioner glued to the tube.
Patient Sequence No: 1, Text Type: N, H10
[92606341]
The foreign distributor ((b)(4)) reported an issue encountered by their customer while using the saddleloop vascular snare. The report stated that the elastic tape (tube) wasn't locked into the slot of the keyhole, and the tensioner was coming off from the tube. The report stated another package of saddleloop was opened and used to successfully complete the surgery. There were no patient complications reported as a result of the alleged issue. The device was returned to the manufacturer for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1649914-2017-00073 |
| MDR Report Key | 7011807 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2017-11-08 |
| Date of Report | 2017-11-28 |
| Date of Event | 2017-08-09 |
| Date Mfgr Received | 2017-08-22 |
| Device Manufacturer Date | 2015-10-02 |
| Date Added to Maude | 2017-11-08 |
| 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 Street | ONE ALLENTOWN PARKWAY |
| Manufacturer City | ALLEN TX 75002 |
| Manufacturer Country | US |
| Manufacturer Postal | 75002 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SADDLELOOP 18G X 10CM WITH BLUNT NEEDLE |
| Generic Name | VASCULAR LOOP |
| Product Code | GAE |
| Date Received | 2017-11-08 |
| Returned To Mfg | 2017-08-25 |
| Model Number | 1541 |
| Lot Number | 0499345C01 |
| Device Expiration Date | 2019-10-01 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | QUEST MEDICAL, INC. |
| Manufacturer Address | ONE ALLENTOWN PARKWAY ALLEN TX 75002 US 75002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-11-08 |