MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-20 for TRUCLEAR 5 OP HYSTERSCOPE 72202976 manufactured by Covidien Lp Llc North Haven.
[95664533]
Post market vigilance (pmv) led an evaluation of one device. A visual inspection was performed and showed distal tip damage, dent in the sheath, and a damaged leaky stopcock. Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all medtronic quality release specifications at the time of manufacture. Analysis concluded there were no assembly component related failures. The instructions for use (ifu) recommends?? Careful inspection of the operative hysteroscope before and after the procedure for possible signs of damage. Immediate detection and repair of minor damage will extend the life of the operative hysteroscope.? Damage may occur if the hysteroscope is handled roughly during use. Excessive forces may result in traumatic insertion, chipping particles of the optical glass, or other damage to the unit. Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[95664534]
According to the reporter, the used device had foggy lens. No additional information given.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219930-2017-10252 |
| MDR Report Key | 7135815 |
| Date Received | 2017-12-20 |
| Date of Report | 2017-12-20 |
| Date of Event | 2017-05-25 |
| Date Mfgr Received | 2017-12-07 |
| Date Added to Maude | 2017-12-20 |
| 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 | SHARON MURPHY |
| Manufacturer Street | 60 MIDDLETOWN AVE |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal | 06473 |
| Manufacturer Phone | 2034925267 |
| Manufacturer G1 | COVIDIEN LP LLC NORTH HAVEN |
| Manufacturer Street | 195 MCDERMOTT RD |
| Manufacturer City | NORTH HAVEN 06473 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06473 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | TRUCLEAR 5 OP HYSTERSCOPE |
| Generic Name | HYSTEROSCOPE ACCESSORIES |
| Product Code | NWW |
| Date Received | 2017-12-20 |
| Returned To Mfg | 2017-06-06 |
| Model Number | 72202976 |
| Catalog Number | 72202976 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN LP LLC NORTH HAVEN |
| Manufacturer Address | 195 MCDERMOTT RD NORTH HAVEN 06473 US 06473 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-20 |