MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-01 for SADDLELOOP 1541 manufactured by Quest Medical, Inc..
[59226180]
Quest medical, inc. Has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported. Quest medical, inc. Defers to the patient's physician regarding medical history.
Patient Sequence No: 1, Text Type: N, H10
[59226181]
The international distributor ((b)(6)) reported an issue encountered with the saddleloop device by one of their customers during a procedure. The report stated that the clinician put the saddleloop around the vessel and attempted to push the needle through the locking mechanism but the tubing was not locked into the slot of the keyhole correctly. As a result, the clinician used a saddleloop device from another package to complete the procedure. The surgery was completed with no patient complications reported. The device was returned to the manufacturer for evaluation.
Patient Sequence No: 1, Text Type: D, B5
[60117595]
Visual examination of the complaint sample found that the tensioner had come off of the tape/silicone tube. No adhesive was seen under black light. The adhesive dispenser was not functioning properly resulting in inadequate amount of adhesive dispensed. The device history record for the lot was reviewed and no devices were rejected and no specific manufacturing yield issues were reported similar to the reported complaint condition.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1649914-2016-00054 |
| MDR Report Key | 6071554 |
| Date Received | 2016-11-01 |
| Date of Report | 2016-11-04 |
| Date of Event | 2016-09-28 |
| Date Mfgr Received | 2016-10-03 |
| Device Manufacturer Date | 2015-11-12 |
| Date Added to Maude | 2016-11-01 |
| 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 | MRS. AMY CLENDENING-WHEELER |
| Manufacturer Street | ONE ALLENTOWN PARKWAY |
| Manufacturer City | ALLEN TX 75002 |
| Manufacturer Country | US |
| Manufacturer Postal | 75002 |
| Manufacturer Phone | 9723326338 |
| Manufacturer G1 | QUEST MEDICAL, INC. |
| Manufacturer Street | ONE ALLENTOWN PARKWAY |
| Manufacturer City | ALLEN TX 75002 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 75002 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SADDLELOOP |
| Generic Name | MANUAL SURGICAL INSTRUMENT |
| Product Code | GAE |
| Date Received | 2016-11-01 |
| Returned To Mfg | 2016-10-10 |
| Model Number | 1541 |
| Lot Number | 0501965N05 |
| Device Expiration Date | 2019-11-11 |
| 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 | 2016-11-01 |