MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-13 for PIPELLE DE CORNIER MARK II 1111200 manufactured by Laboratories Prodimed, Zi.
[23246628]
Patient presented for endometrial biopsy for research clinical trial therapeutics txc12-05. When the pipelle was withdrawn, 3. 5 cm of the outer sheath was missing and was retained in the endometrial cavity. The patient required a hysteroscopy d and c under general anesthesia to retrieve the sheath. Communication from dr. (b)(6). From: (b)(6), sent: tuesday, july 14, 2015 3:05 pm. To: (b)(4). Subject: adverse event with pipelle mark ii. I want to inform you of a product failure that required a surgical procedure to remedy. It is the pipelle mark ii dr. (b)(6), lot # 6103 c909 exp 04/2017. It was used to an endometrial biopsy. The procedure was done in the usual fashion, and was not difficult. When the biopsy instrument was removed approximately 3. 5 cm of the outer sheath was missing and was still inside the uterus. I was unable to remove it in the office and it required a hysteroscopy d and c to remove the retained foreign body. I and the patient want to know if this has happened previously. Thank you. (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1833117-2015-00005 |
| MDR Report Key | 5007300 |
| Date Received | 2015-08-13 |
| Date of Report | 2015-08-11 |
| Date of Event | 2015-05-22 |
| Date Facility Aware | 2015-07-14 |
| Report Date | 2015-08-01 |
| Date Reported to FDA | 2015-08-15 |
| Date Reported to Mfgr | 2015-08-12 |
| Date Added to Maude | 2015-08-17 |
| Event Key | 0 |
| Report Source Code | Distributor 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 |
| Manufacturer Street | 5610 WEST 82ND ST. |
| Manufacturer City | INDIANAPOLIS IN 46278 |
| Manufacturer Country | US |
| Manufacturer Postal | 46278 |
| Manufacturer G1 | CATHETER RESEARCH, INC. |
| Manufacturer Street | 5610 WEST 82ND ST. |
| Manufacturer City | INDIANAPOLIS IN 46278 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46278 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PIPELLE DE CORNIER MARK II |
| Generic Name | ENDOMETRIAL SAMPLER |
| Product Code | HHK |
| Date Received | 2015-08-13 |
| Model Number | 1111200 |
| Catalog Number | 1111200 |
| Lot Number | 6103/C909 |
| Device Expiration Date | 2007-04-01 |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LABORATORIES PRODIMED, ZI |
| Manufacturer Address | 4 RUE DE I EUROPE NEUILLY-EN-THELLE OISE 60530 FR 60530 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-08-13 |