CD001, 10MM RETRIEVAL SYSTEM, 10/BX 100864401

MAUDE Adverse Event Report

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.

Event Text Entries

[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


MAUDE Entry Details

Report Number2027111-2020-00438
MDR Report Key9878808
Report SourceHEALTH PROFESSIONAL,OTHER,USE
Date Received2020-03-25
Date of Report2020-03-25
Date of Event2020-02-04
Date Mfgr Received2020-03-02
Device Manufacturer Date2019-10-22
Date Added to Maude2020-03-25
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactWENDY KOBAYASHI
Manufacturer Street22872 AVENIDA EMPRESA
Manufacturer CityRANCHO SANTA MARGARITA CA 92688
Manufacturer CountryUS
Manufacturer Postal92688
Manufacturer Phone9497138059
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameCD001, 10MM RETRIEVAL SYSTEM, 10/BX
Generic NameLAPAROSCOPE, GENERAL & PLASTIC SURGERY
Product CodeGCJ
Date Received2020-03-25
Model NumberCD001
Catalog Number100864401
Lot Number1372264
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerAPPLIED MEDICAL RESOURCES
Manufacturer Address22872 AVENIDA EMPRESA RANCHO SANTA MARGARITA CA 92688 US 92688


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-25

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