MAUDE Adverse Event Report: MEDICAL DEVICE RESOURCE CORPORATION LS7030; IMPLOSION PROOF CANISTER 3000CC

Model Number LS7030

Device Problem Burst Container or Vessel (1074)

Patient Problems No Consequences Or Impact To Patient (2199); Insufficient Information (4580)

Event Date 10/13/2016

Event Type  malfunction  

Manufacturer Narrative

A ls7030 canister in use with ls2 aspirator is under vacuum, not pressure, and so it could implode not explode.An implosion would release sufficient energy that a customer might think that the canister exploded.A complaint was received reporting that ls7030 exploded at the beginning of procedure.Medical device resource corporation (mdrc) requested customer to send the canister and its pieces back to mdrc for investigation.Another canister from that same lot was used by customer to perform procedure and it worked fine.Canister pieces (equaling about 80% of the canister) and two small pieces of the lid (about 5%) were shipped back.The reassembled canister was carefully inspected (visual inspection) for stress point and/or failure point.Dhr was also reviewed, no discrepancies found.Customer was requested to send canister mount back to mdrc for investigation.We are in the process of performing the investigation and will submit the follow-up report once the evaluation is completed.Investigation in progress.

Event Description

Customer reported that ls7030 exploded at the beginning of procedure.Physician, patient and medical staffs were involved but no injuries noted.There was no biohazard in the canister.Pieces went on the floor and one piece touched the drape, but they were able to isolate this area so no contamination of surgical sites.Another canister was used for procedure and it worked fine.

Manufacturer Narrative

This is a follow-up response to manufacture report number 2938001-2016-00001.Customer was requested to send canister mount back for investigation.Canister mount was received on 09-dec-2016.Provided canister pieces and canister mount have been reviewed by the team.We are unable to provide a conclusive root cause of the reported condition due to missing pieces.A potential root cause for this complaint may be that the canister may have been in place when impact marks were created on the canister mount, causing a stress fracture in the canister as it was impacted within the holder.A corrective action (capa) has been initiated to investigate this issue.Based on the above no further action is required at this time.This complaint will be used for tracking and trending purposes.

• Brand Name: LS7030
• Type of Device: IMPLOSION PROOF CANISTER 3000CC
• Manufacturer (Section D): MEDICAL DEVICE RESOURCE CORPORATION; 5981; graham ct; livermore CA 94550
• Manufacturer (Section G): MEDICAL DEVICE RESOURCE CORPORATION; 5981; graham ct; livermore CA 94550
• Manufacturer Contact: melbourne kimsey ii ; 5981; graham court; livermore, CA 94550 ; 5107329950
• MDR Report Key: 6094307
• MDR Text Key: 60086321
• Report Number: 2938001-2016-00001
• Device Sequence Number: 1
• Product Code: KDQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/01/2018
• Device Model Number: LS7030
• Device Catalogue Number: LS7030
• Device Lot Number: 3MDR-002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Weight: 98 KG