MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-17 for IPAS EASYGRIP CANNULA 8MM SR8-SU manufactured by Pacific Hospital Supply Co., Ltd.
[130969713]
Patient was scheduled for a suction d & c. Due to national back order/shortage of the regular suction d & c tubing (for the d & c machine) the physicians have to use the manual vacuum aspirator and curettes that go with the aspirator. During this case the tip of the curette cannula broke off and was not able to be found. The surgeon then did a hysteroscopy and could not find the missing tip. Another surgeon decided he would do a laparoscopy to look for the missing tip and look for uterine perforation. The laparoscopy was started and it was found that there was a uterine perforation and a hematoma. The broken tip was not found. The surgeon decided to admit the patient for observation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5082219 |
| MDR Report Key | 8175534 |
| Date Received | 2018-12-17 |
| Date of Report | 2018-12-14 |
| Date of Event | 2018-11-09 |
| Date Added to Maude | 2018-12-18 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | IPAS EASYGRIP CANNULA 8MM |
| Generic Name | CATHETER, VENTRICULAR, GENERAL & PLASTIC SURGERY |
| Product Code | GBS |
| Date Received | 2018-12-17 |
| Model Number | SR8-SU |
| Lot Number | 180603 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PACIFIC HOSPITAL SUPPLY CO., LTD |
| Manufacturer Address | MIAOLI, R.O.C TW |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other; 3. Required No Informationntervention | 2018-12-17 |