MAUDE Adverse Event Report: SEISA MEDICAL SALES, LLC DOLPHIN COLLECTION SET (5/PKG); INSUFFLATOR, HYSTEROSCOPIC

Model Number 006775-901

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Patient Involvement (2645)

Event Date 05/12/2020

Event Type  malfunction  

Manufacturer Narrative

Due diligence for additional information was executed.The device is not returned, as such a definitive root cause of the reported complaint cannot be determined at this time.Supplemental report(s) will be filed as the information becomes available.

Event Description

As reported for this event, during preparation for use, the device had a sterility breach of a hair in the canister and was unable to be used.There was no patient involvement.The device was stored in a clear tote on wire shelving units.The package was not damaged upon delivery of the item.

Manufacturer Narrative

The device has been returned and a device evaluation completed for it.This supplemental report is being submitted to provide this information.The customer reported that they found a hair in one of the collection canisters for this device.The device outflow tubing, drape and suction tubing was returned along with the opened tyvek pouch.The customer did not return the collection canisters.The complaint could not be confirmed as the collection canisters were not returned with the device.No hair was observed in the tubing set or on the drape.The device history review (dhr) was performed and there were no abnormalities noted.Since may 2019 additional precautions have been implemented to preclude the occurrence of foreign material contamination on the device.

• Brand Name: DOLPHIN COLLECTION SET (5/PKG)
• Type of Device: INSUFFLATOR, HYSTEROSCOPIC
• Manufacturer (Section D): SEISA MEDICAL SALES, LLC; 9005 montana avenue; el paso TX 79925
• MDR Report Key: 10124654
• MDR Text Key: 199653090
• Report Number: 3003790304-2020-00028
• Device Sequence Number: 1
• Product Code: HIG
• Combination Product (y/n): N
• PMA/PMN Number: K941743
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 006775-901
• Device Lot Number: S1810174
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1