MAUDE Adverse Event Report: GYRUS ACMI, INC. COLLECTION SET, DISPOSABLE WITH HANDLE AND TAPERED FITTING TUBING 6 F; SYSTEM, ABORTION, VACUUM

Model Number 23116

Device Problems Loose or Intermittent Connection (1371); Material Separation (1562); Fitting Problem (2183); Device Fell (4014)

Patient Problem Insufficient Information (4580)

Event Date 01/06/2021

Event Type  malfunction  

Event Description

The curette and adapter would not fit, and the part that slides to initiate suction fell off the device.The tubing was loose and came apart into 2 pieces when it should have been 1 piece.No other tubing was available to replace this one.Tegaderm and steristrips were used to keep device together since tubing is on backorder.

• Brand Name: COLLECTION SET, DISPOSABLE WITH HANDLE AND TAPERED FITTING TUBING 6 F
• Type of Device: SYSTEM, ABORTION, VACUUM
• Manufacturer (Section D): GYRUS ACMI, INC.; 93 north pleasant street; norwalk OH 44857
• MDR Report Key: 11207176
• MDR Text Key: 227944110
• Report Number: 11207176
• Device Sequence Number: 1
• Product Code: HHI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 23116
• Device Lot Number: S2000110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/12/2021
• Event Location: Hospital
• Date Report to Manufacturer: 01/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 18615 DA