MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2018-03-28 for C8301, S ALEXIS WND PROT/RET 5/BX 101355701 manufactured by Applied Medical Resources.
[104034029]
Investigation summary: the event unit was returned to applied medical for evaluation. Visual inspection confirmed the complainant's experience of a torn sheath. Engineering observed cut marks on the sheath near the outer ring, a large tear, and separation of the film from the inner ring. Based on the condition of the returned unit, it is likely that the tear in the sheath was caused by the instrumentation used by the surgeon. The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level. Applied medical continuously seeks to improve the form, function and ease of use of its products. As part of this process, applied medical is currently researching possible updates to product literature and/or device enhancements, which are intended to further minimize the likelihood for this type of event to occur.
Patient Sequence No: 1, Text Type: N, H10
[104034030]
Procedure performed: "herniotomy". Event description: "insert the green ring through the incision. When surgeon curling the white ring but the wound sheath was broken on the green ring. Please consult with photos. " type of intervention: na. Patient status: "no patient injury".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027111-2018-00124 |
| MDR Report Key | 7379897 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2018-03-28 |
| Date of Report | 2018-03-28 |
| Date of Event | 2018-02-01 |
| Date Mfgr Received | 2018-03-13 |
| Device Manufacturer Date | 2017-11-01 |
| Date Added to Maude | 2018-03-28 |
| 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 Street | 22872 AVENIDA EMPRESA |
| Manufacturer City | RANCHO SANTA MARGARITA CA 92688 |
| Manufacturer Country | US |
| Manufacturer Postal | 92688 |
| Manufacturer Phone | 9497138059 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | C8301, S ALEXIS WND PROT/RET 5/BX |
| Generic Name | KGW |
| Product Code | KGW |
| Date Received | 2018-03-28 |
| Returned To Mfg | 2018-02-28 |
| Model Number | C8301 |
| Catalog Number | 101355701 |
| Lot Number | 1310445 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | APPLIED MEDICAL RESOURCES |
| Manufacturer Address | 22872 AVENIDA EMPRESA RANCHO SANTA MARGARITA CA 92688 US 92688 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-28 |