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 2017-06-14 for MEDTRONIC REUSABLE EXTENSION CABLE 53912 manufactured by Oscor Inc..
[77616692]
This complaint is part of internal retrospective review of complaints conducted by oscor, as a result of process improvements made to the complaint system to ensure proper medical device reporting is maintained. As part of the detailed review, this event has been determined to be reportable. This initial mdr is being submitted to meet our requirements of reporting. The cable was returned to the customer for a service analysis; they reported there was no patient involvement. Their analysis revealed the root cause as a negative wire is open (the cable failed the continuity check). The potential cause may be: insufficient strength of the joint. The potential effect to the user/device may be: disruption of the cable function, cable cannot be used properly, and delaying the procedure. A review of the device history record for this cable could not be performed as the lot number is unknown. Based on this investigation a capa has been opened to address this failure. Oscor will continue to monitor this device for complaint trends and risk. Per 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. Oscor inc. Is submitting the above report to comply with 21 cfr part 803, the medical device reporting regulation. The report is based upon information obtained by oscor inc. Which the company may not have been able to investigate or verify prior to the date the report was required by fda.
Patient Sequence No: 1, Text Type: N, H10
[77616693]
Per the customer's service report, the returned cable adapter failed the continuity check, the negative wire is open. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1035166-2017-00048 |
| MDR Report Key | 6641061 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2017-06-14 |
| Date of Report | 2017-06-14 |
| Date of Event | 2016-11-23 |
| Date Mfgr Received | 2016-12-12 |
| Date Added to Maude | 2017-06-14 |
| 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 346831816 |
| Manufacturer Country | US |
| Manufacturer Postal | 346831816 |
| 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 | CABLE, ELECTRODE |
| Product Code | IKD |
| Date Received | 2017-06-14 |
| 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 | 2017-06-14 |