MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,06 report with the FDA on 2008-08-19 for ARTHRO-KNIFE, SERRATED STRAIGHT 2-SIDED ROUND 70-0078-103 manufactured by Conmed Linvatec.
[940437]
The customer reported that during pre-operative testing of this device for a pylormyotomy procedure, the blade did not fully retract into the protective sheath. This event occurred with pre-testing of two knives. A third arthro-knife was obtained and functioned during testing. The third knife was used to complete the procedure. There was no injury or significant surgical delay reported with this event.
Patient Sequence No: 1, Text Type: D, B5
[8192676]
Investigation results: conmed linvatec received this artho-knife for evaluation and the reported event was confirmed. The evaluation found that the end of the knife does not fully retract into the sheath. A corrective action is in process to address this failure mode. Conmed linvatec will continue to monitor this device for failures. Associated mdr: 1017294-2008-00292.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1017294-2008-00293 |
| MDR Report Key | 1135817 |
| Report Source | 00,06 |
| Date Received | 2008-08-19 |
| Date of Report | 2008-07-30 |
| Date of Event | 2008-07-30 |
| Date Mfgr Received | 2008-07-30 |
| Device Manufacturer Date | 2008-02-01 |
| Date Added to Maude | 2010-04-14 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | BEVERLY SCHANER |
| Manufacturer Street | 11311 CONCEPT BLVD. |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Country | US |
| Manufacturer Postal | 33773 |
| Manufacturer Phone | 7273995169 |
| Manufacturer G1 | CONMED LINVATEC |
| Manufacturer Street | 11311 CONCEPT BLVD. |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33773 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARTHRO-KNIFE, SERRATED STRAIGHT 2-SIDED ROUND |
| Generic Name | ARTHRO-CUT KNIFE |
| Product Code | GAC |
| Date Received | 2008-08-19 |
| Returned To Mfg | 2008-08-06 |
| Model Number | NA |
| Catalog Number | 70-0078-103 |
| Lot Number | BBD59412 |
| ID Number | NA |
| Device Expiration Date | 2013-02-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONMED LINVATEC |
| Manufacturer Address | LARGO FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-08-19 |