MAUDE Adverse Event Report: RICHARD WOLF GMBH HYSTERO PUMP 2222; IRRIGATION PUMP

Model Number 2222.001

Device Problems No Audible Alarm (1019); Alarm Not Visible (1022); Insufficient Flow or Under Infusion (2182); Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/03/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation is on-going.The user facility will be contacted to obtain additional information.A follow up will be submitted upon receipt of additional information.

Event Description

On march 24, 2020, richard wolf (b)(4) (rw (b)(4)) received adverse event report number (b)(4).The following was reported: on (b)(6) 2020 the medical staff used the irrigation pump to expand the uterine cavity during the operation.The operating doctor found that the water flow was insufficient and the equipment showed that the pressure and flow were normal.The doctor finally completed the operation under low water flow.The equipment department personnel inspected the equipment and found that the membrane of the tube used for connection was broken and water was seeping, but the equipment could not recognize and alarm.The operation was impacted, but there was no patient harm and no treatment measure was required.

• Brand Name: HYSTERO PUMP 2222
• Type of Device: IRRIGATION PUMP
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• Manufacturer Contact: heiko seider-biedermann ; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 9921369
• MDR Text Key: 204416479
• Report Number: 9611102-2020-00001
• Device Sequence Number: 1
• Product Code: HIG
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K022449
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2222.001
• Device Catalogue Number: 2222.001
• Initial Date Manufacturer Received: 03/24/2020
• Initial Date FDA Received: 04/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other