MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-04-29 for MTO,CANNULA, ROTATABLE, S/V, 5MM 72201693 manufactured by Smith & Nephew, Inc..
[143468281]
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Patient Sequence No: 1, Text Type: N, H10
[143468282]
It was reported that during knee arthroscopic surgery, the medium flow cannula get a sharp edge, causing a potentially cartilage damage. A backup device was available to complete the procedure and no significant delay or patient injuries.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219602-2019-00478 |
| MDR Report Key | 8562304 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-04-29 |
| Date of Report | 2019-07-08 |
| Date of Event | 2019-03-25 |
| Date Mfgr Received | 2019-07-03 |
| Date Added to Maude | 2019-04-29 |
| 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 | JIM GONZALES |
| Manufacturer Street | 7000 WEST WILLIAM CANNON DRIVE |
| Manufacturer City | TX 78735 |
| Manufacturer Country | US |
| Manufacturer Postal | 78735 |
| Manufacturer Phone | 5123585706 |
| Manufacturer G1 | SMITH & NEPHEW, INC. |
| Manufacturer Street | 130 FORBES BOULEVARD |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02048 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MTO,CANNULA, ROTATABLE, S/V, 5MM |
| Generic Name | POLYMER, EAR, NOSE AND THROAT, SYNTHETIC, ABSORBABLE |
| Product Code | NHB |
| Date Received | 2019-04-29 |
| Returned To Mfg | 2019-04-05 |
| Catalog Number | 72201693 |
| Lot Number | 50586108 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW, INC. |
| Manufacturer Address | 130 FORBES BOULEVARD MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-29 |