MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-07-02 for X-PLORE STORZ/LINVATEC BRIDGE REPLACEMENT 283137 manufactured by Depuy Mitek Llc Us.
[113004487]
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. The complaint device was received and reviewed together with an engineer. Visual observation confirms that the spring was missing on the bridge. The body was intact and no anomalies were found. This device needs to be disassembled for cleaning after each use. It is possible that the device was not properly reassembled after cleaning or repeated use and cleaning cycles resulted in the parts loosening up and coming apart. Other than these possibilities, we cannot discern a root cause for this failure mode. A batch record review has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint. Our results indicate that this batch of product was processed without incident and therefore there is no internally assignable cause for the reported problem. Further, a review into the depuy mitek complaints system revealed two other similar complaints for this lot of devices that were released to distribution. Based on the overall complaint rate and customer impact, no further corrective action is warranted at this time. However, depuy mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field. This report is being filed from the remetrex complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
Patient Sequence No: 1, Text Type: N, H10
[113004488]
It was reported by our affiliate parts of the bridge came apart and small spring was lost of the x-plore device and the sheath couldn't be used anymore. This happened before use on the patient. The procedure was continued and successfully completed with a like device. No patient harm or clinically relevant increase in procedure duration reported. Please see also medwatch report 1221934-2018-50962.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221934-2018-50961 |
| MDR Report Key | 7655004 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-07-02 |
| Date of Report | 2013-05-21 |
| Date of Event | 2013-05-21 |
| Date Mfgr Received | 2013-05-21 |
| Device Manufacturer Date | 2012-04-17 |
| Date Added to Maude | 2018-07-02 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. JENNIFER LAWRENCE |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5088808100 |
| Manufacturer G1 | DEPUY MITEK LLC US |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | X-PLORE STORZ/LINVATEC BRIDGE REPLACEMENT |
| Generic Name | RIGID ENDOSCOPE SHEATH |
| Product Code | NLR |
| Date Received | 2018-07-02 |
| Returned To Mfg | 2013-06-10 |
| Catalog Number | 283137 |
| Lot Number | 12/03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | DEPUY MITEK LLC US |
| Manufacturer Address | 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-02 |