MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2017-01-16 for INDICATOR SHAFT 0695S manufactured by Megadyne Medical Products, Inc.
[64889454]
Without lot number information, we are unable to identify the manufacturing date. Complaint history for the last 2 years does not show any reports due to this same report. The shaft is sold as a non-sterile device and indented for sterilization by the user facility and intended for the attachment of a sterile tip. At this time, all attempts to gain access to the device or additional information have been unsuccessful. A review of product history reveals this device to be a reliable component of electrosurgery and there is no evidence to suggest device defect or malfunction. Megadyne determined to report this event based on information that a burn occurred on the patient's fallopian tubes and intervention may have been required. Megadyne has requested additional information and made requests for the device to be returned for further investigation and evaluation.
Patient Sequence No: 1, Text Type: N, H10
[64889455]
Two (2)x gynnae patients fallopian tubes were burnt in surgery while using megatip and reusable indicator shaft.
Patient Sequence No: 1, Text Type: D, B5
[65406825]
Two devices were received and were reported as 0695s. Upon examination of the samples it was found that the devices were not manufactured by megadyne medical products. We consider this matter to be closed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1721194-2017-00003 |
| MDR Report Key | 6253901 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2017-01-16 |
| Date of Report | 2017-01-19 |
| Date of Event | 2016-12-01 |
| Date Mfgr Received | 2016-12-19 |
| Date Added to Maude | 2017-01-16 |
| 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. JOHN BLIGHT |
| Manufacturer Street | 11506 SOUTH STATE STREET |
| Manufacturer City | DRAPER UT 84020 |
| Manufacturer Country | US |
| Manufacturer Postal | 84020 |
| Manufacturer Phone | 8015769669 |
| Manufacturer G1 | MEGADYNE MEDICAL PRODUCTS, INC |
| Manufacturer Street | 11506 SOUTH STATE STREET |
| Manufacturer City | DRAPER UT 84020 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 84020 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INDICATOR SHAFT |
| Generic Name | INDICATOR SHAFT |
| Product Code | JOS |
| Date Received | 2017-01-16 |
| Returned To Mfg | 2017-01-17 |
| Model Number | 0695S |
| Catalog Number | 0695S |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEGADYNE MEDICAL PRODUCTS, INC |
| Manufacturer Address | 11506 SOUTH STATE STREET DRAPER UT 84020 US 84020 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-01-16 |