MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2016-06-23 for WALLACE OOCYTE RECOVERY SYSTEMS N/A ON1733 manufactured by Smiths Medical International, Ltd.
[48049545]
Customer has not yet returned the device to the manufacturer for device evaluation. When and if the device becomes available and is returned and evaluated the manufacturer will file a follow-up report detailing the results of the evaluation.
Patient Sequence No: 1, Text Type: N, H10
[48049546]
Distributor reported that the physician observed rough needle tips during oocyte recovery procedures. This was observed 15 times out of approximately 50 procedures. The patient's experienced internal bleeding, up to 600 mls, as well as 100-150 ml externally. As a result of the internal bleeding, all patients received hemostatic therapy. Some patient's required surgical treatment, including suturing of the ovary and puncture site. All of the patients recovered. Individual patient details were not provided.
Patient Sequence No: 1, Text Type: D, B5
[57829842]
The reported wallace oocyte recovery set 17g, 10/ca used devices were destroyed. There were images provided by the customer, and it was observed that the tips of the needles were damaged. The complaints were confirmed the needle tip was observed to be damaged. Mfr# clarification: new registration number 3012307300 (b)(4) has been received, however, this initial mdr was filed under the prior registration number 2183502 (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[60671338]
Thirty unused wallace? Oocyte recovery systems were returned for evaluation. Visual inspection found that the needle protector were in good condition to assure safe handling. Microscopic visual inspection found no damage and that the devices were found within specification. Functional testing involved a penetration test and all samples were found within specification. Retained samples from a different lot were visually and functionally tested and were found within specification. A gage repeatability and reproducibility study was performed on the part and all personnel detected damaged devices appropriately. Photos of the actual devices were provided by the customer and it was observed that the tips of the needle were damaged. Based on the evidence, the root cause was unable to be determined and all returned and retained devices were found within specification. The complaint was confirmed based on the observed photographic evidence. There was no evidence found to suggest the event was caused from an intrinsic defect in the product.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183502-2016-01237 |
| MDR Report Key | 5745440 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2016-06-23 |
| Date of Report | 2016-05-25 |
| Date Mfgr Received | 2016-10-25 |
| Device Manufacturer Date | 2015-07-17 |
| Date Added to Maude | 2016-06-23 |
| 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 | MICHELE SELIGA |
| Manufacturer Street | 1265 GREY FOX ROAD |
| Manufacturer City | ST PAUL 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 7633833052 |
| Manufacturer G1 | SMITHS MEDICAL INTERNATIONAL, LTD |
| Manufacturer Street | BOUNDARY ROAD |
| Manufacturer City | HYTHE, KENT CT216JL |
| Manufacturer Country | UK |
| Manufacturer Postal Code | CT21 6JL |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WALLACE OOCYTE RECOVERY SYSTEMS |
| Generic Name | NEEDLE, ASSISTED REPRODUCTION |
| Product Code | MQE |
| Date Received | 2016-06-23 |
| Model Number | N/A |
| Catalog Number | ON1733 |
| Lot Number | 3003611 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL INTERNATIONAL, LTD |
| Manufacturer Address | MARK UPTON BOUNDARY ROAD HYTHE, KENT CT216JL UK CT21 6JL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-06-23 |