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 2016-09-13 for MEDTRONIC REUSABLE EXTENSION CABLE 53912 manufactured by Oscor Inc..
[54539003]
The device was in use for treatment. The device was not returned for evaluation; as a result, the allegations against this cable cannot be confirmed. A review of the device history records could not be performed as the lot number of the device is unknown. As the device was not returned for analysis, the root cause of the failure could not be determined. Potential cause of this failure: insufficient strength of soldered joint. Since the separation between the cable wire and the soldered pin may cause a disruption of the cable function, a corrective and preventive action has been opened to address this failure. Per the cable inspection procedure, during in process inspection the cable is inspected 100% for continuity. During final inspection, each strand of the cable is checked for the correct colored part, overall length of the cable, cable checked for damage and insulation voids, verification that the silicone strain relief extends at least for a length of 2 cm outside the female connector, checked that the silicone strain relief fits the wire snugly, checks for strain relieves for damage and gaps, a pull test is done on each connector and pin and the cable is inspected again for continuity. The instructions for use (ifu) informs the user: for reusable cables only: the cables can be re-sterilized by oscor eto gas sterilization a maximum of two times. The directions for use inform the user to: first attach the proximal connector(s) to a pacemaker/analyzer or another extension cable while observing polarity indicated by the color. Then attach the distal connector(s) to the temporary lead connector or to another extension cable, again observing polarity by the color. The detachment of the connection should be done in the reverse order. Precautions include: do not connect any cable model to a/c power source; connection of exposed pins to a/c power source may pose a risk of serious injury or death. Extension cables are not intended for use with apnea monitors.
Patient Sequence No: 1, Text Type: N, H10
[54539004]
The customer reported that the cable's wire pulled out of the red and black connectors. There was no patient complication as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1035166-2016-00152 |
| MDR Report Key | 5945685 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2016-09-13 |
| Date of Report | 2016-08-15 |
| Date of Event | 2016-08-11 |
| Date Mfgr Received | 2016-08-15 |
| Date Added to Maude | 2016-09-13 |
| 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 DORIT SEGAL |
| Manufacturer Street | 3816 DESOTO BLVD. |
| Manufacturer City | PALM HARBOR FL 346831618 |
| Manufacturer Country | US |
| Manufacturer Postal | 346831618 |
| Manufacturer Phone | 7279372511 |
| Manufacturer G1 | OSCOR INC. |
| Manufacturer Street | 3816 DESOTO BLVD. |
| Manufacturer City | PALM HARBOR FL 346831816 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 346831816 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDTRONIC REUSABLE EXTENSION CABLE |
| Generic Name | ELECTRODE CABLE |
| Product Code | IKD |
| Date Received | 2016-09-13 |
| Model Number | 53912 |
| Catalog Number | 53912 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OSCOR INC. |
| Manufacturer Address | 3816 DESOTO BLVD. PALM HARBOR FL 346831816 US 346831816 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-09-13 |