MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08,distributor,user facility report with the FDA on 2015-06-26 for LOOP 7813-1 20PK PRESHAPED BRUNNINGS manufactured by Integra Microfrance S.a.s..
[15570169]
Customer initially reports loop broke. On (b)(6) 2015 customer reports that during a tonsillectomy the loop broke into two pieces that did not fail into the pt, they were removed from the snare. A replacement snare was used. No harm done.
Patient Sequence No: 1, Text Type: D, B5
[15642513]
To date the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based on the reported info.
Patient Sequence No: 1, Text Type: N, H10
[65725045]
On (b)(6) 2015 integra investigation completed. Manufacture date unk. Method: failure analysis: device history evaluation. Results: failure analysis - the wire is broken. There is no evidence of any manufacturing or material defect. Device history evaluation: no nonconformity for this lot. Conclusion: the wire was probably broken by an inappropriate use of the instrument.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2015-00039 |
| MDR Report Key | 4875612 |
| Report Source | 08,DISTRIBUTOR,USER FACILITY |
| Date Received | 2015-06-26 |
| Date of Report | 2015-06-09 |
| Date of Event | 2015-06-05 |
| Date Mfgr Received | 2015-07-07 |
| Date Added to Maude | 2015-07-23 |
| 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 | SANDRA LEE |
| Manufacturer Street | 315 ENTERPRISE DRIVE |
| Manufacturer City | PLAINBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099366828 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LOOP 7813-1 20PK PRESHAPED BRUNNINGS |
| Generic Name | PFM11 |
| Product Code | EIF |
| Date Received | 2015-06-26 |
| Returned To Mfg | 2015-06-26 |
| Catalog Number | 7813-1 |
| Lot Number | 140701 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA MICROFRANCE S.A.S. |
| Manufacturer Address | SAINT AUBIN LE MONIAL 03160 FR 03160 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-06-26 |