MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-04-11 for WELL LEG HOLDER 72200632 manufactured by Smith & Nephew Endoscopy Andover Manufacturing.
[1863483]
The patient was under anesthesia, the foot piece on the leg holder cracked and broke off during the procedure. Case had to be cancelled.
Patient Sequence No: 1, Text Type: D, B5
[9177071]
Returned device was sent to vendor for evaluation, pending investigation result. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[18736656]
The product was sent to (b)(4) medical for evaluation and confirm the customer complaint for the foot piece breaking off. The shaft pivot pin has had the head pulled thru the foot plate. A corrective action was opened and previously completed to address this issue. This product was manufactured in (b)(6) 2008 and predates the design change. The eco was approved on (b)(6) 2009 and the fmea was implemented on (b)(6) 2009. No further investigation is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003604053-2011-00006 |
| MDR Report Key | 2048367 |
| Report Source | 07 |
| Date Received | 2011-04-11 |
| Date of Report | 2011-03-15 |
| Date of Event | 2011-03-15 |
| Date Facility Aware | 2011-03-15 |
| Date Mfgr Received | 2011-03-15 |
| Device Manufacturer Date | 2008-09-01 |
| Date Added to Maude | 2011-10-12 |
| 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 | JASON BILOBRAM |
| Manufacturer Street | 150 MINUTEMAN ROAD |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal | 01810 |
| Manufacturer Phone | 9787491630 |
| Manufacturer G1 | ANDOVER MANUFACTURING SITE |
| Manufacturer Street | 150 MINUTEMAN ROAD |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01810 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WELL LEG HOLDER |
| Generic Name | WELL LEG HOLDER |
| Product Code | JEB |
| Date Received | 2011-04-11 |
| Returned To Mfg | 2011-03-25 |
| Model Number | 72200632 |
| Catalog Number | 72200632 |
| Lot Number | 329827 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 30 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW ENDOSCOPY ANDOVER MANUFACTURING |
| Manufacturer Address | 150 MINUTEMAN ROAD ANDOVER MA 01810 US 01810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-04-11 |