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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CD001, 10MM RETRIEVAL SYSTEM, 10/BX LAPAROSCOPE, GENERAL & PLASTIC SURGERY

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APPLIED MEDICAL RESOURCES CD001, 10MM RETRIEVAL SYSTEM, 10/BX LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Model Number CD001
Device Problem Difficult to Open or Close (2921)
Patient Problem Injury (2348)
Event Date 08/25/2019
Event Type  Malfunction  
Manufacturer Narrative

No product is being returned for evaluation and no lot # has been provided to manufacturer. A final report will be sent once the results have been analyzed.

 
Event Description

Procedure performed: laparoscopic cholecystectomy. Dr performing a lap chole experienced issues with cd001. Dr has used this bag for many years. Dr was using cff03 and cor47 port, dr placed the gallbladder in the cd001 and pulled the string to tighten the bag ready for retrieval. Dr said the bag did not close correctly and it leaked bile into the abdomen resulting him in having to wash the abdomen with 6 litres of ns and the patient has had to stay in hospital with 2 drains post op. Dr said that this issue had occurred repeated itself 3 times now on separate occasion. The device was not kept due to its condition after the leak. Additional information received from sales rep via email on 02sep2019: i think i did state that the bag leaked at the bead end and did not close properly and did not burst in my original cer. Additional information received from sales rep via email on 19sep2019: he cannot remember when the other 2 times occurred unfortunately. Patient status: stayed in hospital for a number of days with 2 drains in abd complaining. Type of intervention: washed the abdomen with 6l of ns and patient had to stay in hospital with 2 drains post op.

 
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Brand NameCD001, 10MM RETRIEVAL SYSTEM, 10/BX
Type of DeviceLAPAROSCOPE, GENERAL & PLASTIC SURGERY
Manufacturer (Section D)
APPLIED MEDICAL RESOURCES
22872 avenida empresa
rancho santa margarita CA 92688
Manufacturer Contact
wendy kobayashi
22872 avenida empresa
rancho santa margarita, CA 92688
9497138059
MDR Report Key9121065
MDR Text Key177966929
Report Number2027111-2019-00599
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
Reporter Country CodeAS
PMA/PMN NumberK060051
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/21/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/25/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberCD001
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/26/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 09/25/2019 Patient Sequence Number: 1
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