MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other,use report with the FDA on 2020-03-25 for CD001, 10MM RETRIEVAL SYSTEM, 10/BX 100864401 manufactured by Applied Medical Resources.
[184880166]
The event unit is anticipated to return for evaluation. A follow-up report will be provided upon completion of the investigation. This report is in response to medwatch uf/importer report #4900240000-2020-8019.
Patient Sequence No: 1, Text Type: N, H10
[184880167]
Name of procedure being performed: laparoscopic cholecystectomy. Detailed description of event: from medwatch uf/importer report #4900240000-2020-8019 received via mail on march 2nd, 2020. The date of event was in february 2020. The product is available for return. "event description: while using retrieval bag for gallbladder; bag ripped at seam. " per operative report: preoperative diagnosis: symptomatic cholelithiasis. Postoperative diagnosis: symptomatic cholelithiasis. Procedure performed: laparoscopic cholecystectomy. "gallbladder was placed in [device] and removed from umbilical trocar site. While doing so, the stone became lodged to the level of fascia and the bag actually separated leaving the stone impacted at the fascial edges. An additional bag was used to place the stone in, and then was subsequently removed without issue. Operative filed was examined and noted to be hemostatic. " the original intended procedure was a cholecystectomy, laparoscopic [47562 (cpt)]. The problem the user had was the device failed (e. G. Broke, couldn't get it to work, or stopped working. Additional information was received from bsn, rn, perioperative quality specialist, via e-mail on march 4th, 2020 at 0942: the date of incident was february 4th, 2020. It has been confirmed that no patient injury or illness occurred associated with the complaint event. Regarding patient status, per the operative report, "the patient tolerated the procedure well without any apparent complication and after a debrief, was awakened and transferred to pacu in stable condition. " it has been confirmed that the specimen was inside the bag when the bag burst - the same information from the operative report in the medwatch's event description was provided. [device] is mentioned as the endocatch bag. There were other instruments being used alongside the cd001, but the particulars are unknown. Additional information was received from bsn, rn, perioperative quality specialist, via e-mail on march 4th, 2020 at 1756: "although the operative note states endocatch bag, the surgeon is referring to the cd001, inzii retrieval bag which contained the gallbladder. " patient status: "per the operative report, the patient tolerated the procedure well without any apparent complication and after a debrief, was awakened and transferred to pacu in stable condition. " type of intervention: "an additional bag was used to place the stone in, and then was subsequently removed without issue. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027111-2020-00438 |
| MDR Report Key | 9878808 |
| Report Source | HEALTH PROFESSIONAL,OTHER,USE |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-02-04 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2019-10-22 |
| Date Added to Maude | 2020-03-25 |
| 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 | WENDY KOBAYASHI |
| Manufacturer Street | 22872 AVENIDA EMPRESA |
| Manufacturer City | RANCHO SANTA MARGARITA CA 92688 |
| Manufacturer Country | US |
| Manufacturer Postal | 92688 |
| Manufacturer Phone | 9497138059 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CD001, 10MM RETRIEVAL SYSTEM, 10/BX |
| Generic Name | LAPAROSCOPE, GENERAL & PLASTIC SURGERY |
| Product Code | GCJ |
| Date Received | 2020-03-25 |
| Model Number | CD001 |
| Catalog Number | 100864401 |
| Lot Number | 1372264 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | APPLIED MEDICAL RESOURCES |
| Manufacturer Address | 22872 AVENIDA EMPRESA RANCHO SANTA MARGARITA CA 92688 US 92688 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-25 |