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 2019-05-15 for COUPLER, ZOOM, HD, C-MOUNT AR-3210-0006 manufactured by Arthrex, Inc..
[145092723]
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation. The root cause of the event could not be determined from the information available and without device evaluation.
Patient Sequence No: 1, Text Type: N, H10
[145092724]
It was reported that upon inspection of the c-mount zoom coupler, ar-3210-0006, it had clear visible damage and the coupler did not screw into the scope properly. The broken coupler was tagged for isolation and, in this instance, it was not used. Unfortunately it was put back into service and the next surgeon operated using the damaged coupler. During a cystoscopy procedure, the c-mount zoom coupler, ar-3210-0006, was used and pierced the patient's bladder wall leading to an overnight stay in the hospital to monitor patients condition. No further details provided, additional information has been requested. Additional information provided 5/1/2019: the zoom optical c-mount coupler was not able to screw in properly to the c-mount camera. During the operation the coupler disengaged from the camera and the scope inadvertently pierced the patients bladder wall. The scope used was not an arthrex scope. At this stage the primary objective of the cystoscopy was already completed and the surgeon was happy to end the case. The patient was admitted overnight post surgery for observation purposes. No subsequent issues were reported and they where allowed to go home the following morning.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220246-2019-01097 |
| MDR Report Key | 8611494 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-05-15 |
| Date of Report | 2019-06-18 |
| Date of Event | 2019-04-17 |
| Date Mfgr Received | 2019-04-24 |
| Device Manufacturer Date | 2018-12-12 |
| Date Added to Maude | 2019-05-15 |
| 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 | VIK BAJNATH |
| Manufacturer Phone | 8009337001 |
| Manufacturer G1 | ARTHREX, INC. |
| Manufacturer Street | 1370 CREEKSIDE BOULEVARD |
| Manufacturer City | NAPLES FL 341081945 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 341081945 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COUPLER, ZOOM, HD, C-MOUNT |
| Generic Name | INSTRUMENT, SPECIAL LENS, FOR ENDOSCOPE |
| Product Code | FEI |
| Date Received | 2019-05-15 |
| Model Number | COUPLER, ZOOM, HD, C-MOUNT |
| Catalog Number | AR-3210-0006 |
| Lot Number | 10262343 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARTHREX, INC. |
| Manufacturer Address | 1370 CREEKSIDE BOULEVARD NAPLES FL 341081945 US 341081945 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-05-15 |