MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2016-02-03 for CRYOTIP IST-063A manufactured by Irvine Scientific Sales Co., Inc..
[37607686]
The end user, customer, reported to the irvine scientific technical application scientist the event that occurred on (b)(6) 2015 when the embryos were thawed. Technical application scientist was contacted by the end user on 01/04/2016. Additional device: lot # 40709, catalog # ist-067a, date of manufacture 02/23/2012, expiry date 05/30/2014. (b)(6). Loss of cells (human embryos). Unable to enter device code mqh, microtools, assisted reproduction (pipettes). End user reported that the medical device, cryotip, cracked during the thawing process and the patient embryos were not recovered. The medical device was discarded by the end user following the event that occurred on (b)(6) 2015 and was reported to the technical application scientist on 01/04/2016. The medical device was not available for return to the manufacturer for investigation as it was discarded after thawing. The technical application specialist, an employee of irvine scientific, was contacted by the customer, end user, on 01/04/2016 regarding the thawing of the medical device, cryotip, that occurred on (b)(6) 2015. The technical application specialist spoke with the end user to con firm that they had been trained in the use of the cryotip as part of the investigation. Irvine scientific sales co. , inc. Is filing this mdr with an abundance of caution. This mdr submission is our initial and final report. A follow up report will not be submitted.
Patient Sequence No: 1, Text Type: N, H10
[37607687]
The end user reported that the medical device, cryotip, containing human embryos cracked during the thawing process and the patient embryos were not recovered.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2022379-2016-00001 |
| MDR Report Key | 5412835 |
| Report Source | OTHER |
| Date Received | 2016-02-03 |
| Date of Report | 2016-02-02 |
| Date of Event | 2015-12-10 |
| Date Mfgr Received | 2016-01-04 |
| Device Manufacturer Date | 2011-10-27 |
| Date Added to Maude | 2016-02-05 |
| 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 | MS JAYME YAMAGUCHI-OWENS |
| Manufacturer Street | 2511 DAIMLER ST |
| Manufacturer City | SANTA ANA CA 92705 |
| Manufacturer Country | US |
| Manufacturer Postal | 92705 |
| Manufacturer Phone | 9492617800 |
| Manufacturer G1 | IRVINE SCIENTIFIC SALES CO., INC. |
| Manufacturer Street | 2511 DAIMLER ST |
| Manufacturer City | SANTA ANA CA 92705 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92705 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CRYOTIP |
| Generic Name | CRYOTIP |
| Product Code | MQH |
| Date Received | 2016-02-03 |
| Catalog Number | IST-063A |
| Lot Number | 40709 |
| Device Expiration Date | 2014-01-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IRVINE SCIENTIFIC SALES CO., INC. |
| Manufacturer Address | 2511 DAIMLER ST SANTA ANA CA 92705 US 92705 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-02-03 |