MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-15 for SADDLELOOP 1541 manufactured by Quest Medical, Inc..
[40782019]
Visual examination of the complaint sample confirmed the alleged complaint condition. Insufficient adhesive and/or inadequate adhesive-curing time appears to have resulted in the tensioner to come off the device during use. There are no more devices of this lot remaining in inventory for additional analysis. 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. 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
[40782020]
The hospital supply chain coordinator reported an issue with the saddleloop device during use. They reported that during an open-heart procedure the plastic locking mechanism popped off as soon as it was cinched down on the vessel. The report stated the surgeon had to "improvise" to complete the procedure. The complainant reported the issue has occurred before in prior surgeries but they are just now reporting it. There were no patient complications reported as a result of the alleged issue. The device was returned to the manufacturer for analysis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1649914-2016-00006 |
| MDR Report Key | 5501378 |
| Date Received | 2016-03-15 |
| Date of Report | 2016-02-23 |
| Date of Event | 2016-02-23 |
| Date Mfgr Received | 2016-02-23 |
| Device Manufacturer Date | 2015-10-01 |
| Date Added to Maude | 2016-03-15 |
| 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 | 0 |
| Brand Name | SADDLELOOP |
| Generic Name | MANUAL SURGICAL INSTRUMENT (CLAMP, RETRACTOR) |
| Product Code | GAE |
| Date Received | 2016-03-15 |
| Returned To Mfg | 2016-02-25 |
| Model Number | 1541 |
| Lot Number | 0499345C01 |
| Device Expiration Date | 2019-10-01 |
| Operator | PHYSICIAN |
| Device Availability | R |
| 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 | 2016-03-15 |