MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-12-20 for TROCAR CANNULA STABILITY SLEEVE XCEL ETHCB12LT manufactured by Sterilmed, Inc..
[131384672]
Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made. There are no observed discrepancies upon review of the related device history record (dhr). No conclusion can be determined from the dhr as to a cause of the reported issue. Manufacturer's ref. No: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[131384673]
It was reported that a patient underwent a procedure with a trocar cannula stability sleeve xcel and the customer believed the device was not properly sanitized because it contained contaminants. During pre-op, when the device was removed the packaging the issue was noticed. The device did not come in contact with the patient. A new alternative device was opened and used to complete the procedure. The intent of the procedure was not altered as a result. There were no reported patient consequences. This event has been assessed as mdr reportable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134070-2018-00115 |
| MDR Report Key | 8187888 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-12-20 |
| Date of Report | 2018-11-28 |
| Date Mfgr Received | 2019-01-24 |
| Device Manufacturer Date | 2018-05-16 |
| Date Added to Maude | 2018-12-20 |
| 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 | MR. GABRIEL ALFAGEME |
| Manufacturer Street | 5010 CHESHIRE PARKWAY STE 2 |
| Manufacturer City | PLYMOUTH MN 55446 |
| Manufacturer Country | US |
| Manufacturer Postal | 55446 |
| Manufacturer Phone | 9497898687 |
| Manufacturer G1 | STERILMED, INC. |
| Manufacturer Street | 5010 CHESHIRE PARKWAY STE 2 |
| Manufacturer City | PLYMOUTH MN 55446 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55446 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TROCAR CANNULA STABILITY SLEEVE XCEL |
| Generic Name | LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED |
| Product Code | NLM |
| Date Received | 2018-12-20 |
| Catalog Number | ETHCB12LT |
| Lot Number | 2050922 |
| Device Expiration Date | 2019-05-16 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERILMED, INC. |
| Manufacturer Address | 5010 CHESHIRE PARKWAY STE 2 PLYMOUTH MN 55446 US 55446 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-20 |