MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2019-05-21 for UROPASS AS 11/13FR X 38 CM 5/BX 61138BX manufactured by Teleflex Medical Oem.
[145752011]
The device was returned to the service center and pending investigation. The cause of the reported event cannot be determined. However, based on the reported information, the operator? S technique cannot be ruled out as a contributory factor of the reported event. The reported event is listed as a potential complication that can occur during operation. The instruction manual (section 3. 0) states,? Patients or their representatives should be informed of the possible complications associated with the use of this product.? Gyrus acmi requests that physicians notify the company of complications that may occur with the use of this device. Complications may include but are not limited to mucosal irritation, inflammation and perforation of the urethra, bladder, or ureter. ? In addition, do not apply excessive force to the product or use it excessively. It is likely to injure or cause perforation in the urinary tract of the patient.? The instruction manual states? Advance the dilator/sheath assembly over the guidewire to the desired location. If resistance is encountered, stop! Do not advance against resistance. Damage to the anatomy could result.?
Patient Sequence No: 1, Text Type: N, H10
[145752012]
The service center was informed that during a therapeutic total laparoscopic hysterectomy (tlh) procedure, the proximal end of the device broke. No pieces fell into the patient. No bleeding reported. No longer needed stay or additional procedures. The procedure was prolonged by a few minutes. The procedure was completed using non-olympus equipment. There was no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2019-00859 |
| MDR Report Key | 8629876 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-05-21 |
| Date of Report | 2019-07-09 |
| Date of Event | 2019-04-22 |
| Date Mfgr Received | 2019-06-13 |
| Date Added to Maude | 2019-05-21 |
| 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. CONNIE TUBERA |
| Manufacturer Street | 2400 RINGWOOD AVENUE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4089355124 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UROPASS AS 11/13FR X 38 CM 5/BX |
| Generic Name | UROPASS ACCESS SHEATH |
| Product Code | KNY |
| Date Received | 2019-05-21 |
| Returned To Mfg | 2019-05-06 |
| Model Number | 61138BX |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL OEM |
| Manufacturer Address | 3750 ANNAPOLIS LANE NORTH, SUITE 160 PLYMOUTH MN 55447 US 55447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-21 |