MAUDE Adverse Event Report: MGS GROUP NORTH AMERICA SAFETOUCH COLLECTION SYSTEM (10/PK); SYSTEM, ABORTION, VACUUM

Model Number	003984-901
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/20/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reports, due insufficient supply of canister lids with their stock of safe touch collection systems, the customer "rigged" an alternative suction set up using different canister lids.The customer contacted olympus to get additional canister lids and was informed the item is on back order at this time and could not be shipped.Once informed of the back order, the customer requested emergency permission to reprocess and re-use the safe touch collection system (lids).The customer was informed per the instructions for use the collection canisters and lids are for single use only and should not be reprocessed or reused.During a dilation and evacuation procedure using the "rigged" suction set up, a patient "nearly bled to death" due to inadequate suction created by the alternative suction set up.Additional details regarding the patient and reported event have been requested.At this time, no additional information has been provided.
Additional Manufacturer Narrative
The device referenced in this report has not been returned to olympus for evaluation.The definitive cause of the user's experience cannot be determined at this time.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.
Additional Manufacturer Narrative
This report is being updated to provide investigation findings.New information is reported in h6 and h10.Physical evaluation of the device cannot be performed as the customer is not returning device.In addition, many unsuccessful attempts were made to reach out to the customer to retrieve more information to better understand the issue.A dhr review cannot be completed as the device is not being returned and the lot number was not provided by the customer after multiple requests.In summary, the risk has been measured to have a max severity rating of 5, a low occurrence rating of 1, and deemed a low level of risk.The risk assessment goes further to state that the failure is likely due to a misuse of the product and that a training program is recommended to educate consumers of the potential effects of failure.A letter was sent out by the olympus urology team on march 1st, 2022.This letter was sent out to address the backorder issue and to provide ongoing information about the status of production and delivery.

• Brand Name: SAFETOUCH COLLECTION SYSTEM (10/PK)
• Common Device Name: SYSTEM, ABORTION, VACUUM
• Manufacturer (Section D): MGS GROUP NORTH AMERICA; w190 n11701 moldmakers way; germantown WI 53022 8214
• Manufacturer Contact: kenneth pittman ; 800 west park drive; westborough, MA 01581 ; 9013785969
• MDR Report Key: 13550428
• Report Number: 3003790304-2022-00026
• Device Sequence Number: 3818857
• Product Code: HHI
• UDI-Device Identifier: 00821925037885
• UDI-Public: 00821925037885
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K030935
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 003984-901
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2022
• Supplement Date Received by Manufacturer: 04/06/2022
• Initial Report FDA Received Date: 02/17/2022
• Supplement Report FDA Received Date: 05/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Life Threatening
• Patient Sex: Female