MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-11-08 for SPIDER FLEXIBLE CLIP APPLIER 9000029 manufactured by Transenterix, Inc..
[3000027]
During an abdominal laparoscopic cholecystectomy procedure the surgical sales rep indicated that the clip applier had difficulty closing clips.
Patient Sequence No: 1, Text Type: D, B5
[10318900]
Upon investigation of complaints related to clip applier functionality, a non-safety related quality issue was identified. The decision was made to recall the clip applier product and a recall was executed on (b)(4) 2012. Fda was notified on (b)(4) 2012. (b)(4). During the recall closure and in discussions with fda on (b)(4) 2012, it was determined that mdrs should be filed to ensure complete documentation. This mdr is being filed retrospectively.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007593944-2012-00015 |
| MDR Report Key | 2844246 |
| Report Source | 05 |
| Date Received | 2012-11-08 |
| Date of Report | 2012-06-19 |
| Date of Event | 2012-06-19 |
| Date Mfgr Received | 2012-06-19 |
| Device Manufacturer Date | 2012-03-01 |
| Date Added to Maude | 2013-02-14 |
| 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 | MS. TAMMY CARREA |
| Manufacturer Street | 635 DAVIS DRIVE SUITE 300 |
| Manufacturer City | DURHAM NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9197658420 |
| Manufacturer Street | 2633 S. MIAMI SUITE 119 |
| Manufacturer City | DURHAM NC 27703 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27703 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | Z-2137-2012 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPIDER FLEXIBLE CLIP APPLIER |
| Generic Name | LAPAROSCOPIC, GENERAL AND PLASTIC SURGERY |
| Product Code | OTJ |
| Date Received | 2012-11-08 |
| Returned To Mfg | 2012-06-22 |
| Model Number | 9000029 |
| Catalog Number | 9000029 |
| Lot Number | DC082122 |
| ID Number | NA |
| Device Expiration Date | 2014-02-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TRANSENTERIX, INC. |
| Manufacturer Address | DURHAM NC US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-11-08 |