MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-15 for SPECULUM MCO981D DEVEZE manufactured by Integra Microfrance S.a.s..
[93177087]
Integra has completed their internal investigation on november 13, 2017. Results: evaluation of returned device; the laser welding between speculum and frame is cracked. There is not fragment. A thorough observation of welding did not highlighted welding defect. Dhr review; (always include dhr review, if lot number or device not provided, explain why). No anomalies that could be associated with the complaint were observed. Complaints history; no adverse trend - first occurrence of this risk for this device. Conclusion: the origin of the crack cannot be determined with certainty. The most probable cause is an excessive constraint on the speculum.
Patient Sequence No: 1, Text Type: N, H10
[93177088]
It was reported that the device seal broke. Product was in contact with the patient; however, no patient injury reported and the event lead to 45 minutes surgical delay.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523190-2017-00136 |
| MDR Report Key | 7032551 |
| Date Received | 2017-11-15 |
| Date of Report | 2017-11-07 |
| Date Mfgr Received | 2017-11-07 |
| Device Manufacturer Date | 2017-06-09 |
| Date Added to Maude | 2017-11-15 |
| 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | USER SONIA IRIZARRY |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA MICROFRANCE S.A.S. |
| Manufacturer Street | LE PAVILLON |
| Manufacturer City | SAINT AUBIN LE MONIAL 03160 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 03160 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SPECULUM MCO981D DEVEZE |
| Generic Name | PFM11 |
| Product Code | EPY |
| Date Received | 2017-11-15 |
| Returned To Mfg | 2017-11-07 |
| Catalog Number | MCO981D |
| Lot Number | 2172172 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA MICROFRANCE S.A.S. |
| Manufacturer Address | LE PAVILLON LE PAVILLON SAINT AUBIN LE MONIAL 03160 FR 03160 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-15 |