MAUDE Adverse Event Report: CAREFUSION, INC HUNTER LARGE UTERINE CURETTE 3CM BLD 8IN; CURETTE, UTERINE

Model Number	GL1625
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) initial emdr.A device is anticipated for investigation.Once the investigation has been completed a supplemental emdr will be submitted for the investigation results.If any additional information is received a supplemental will be submitted with those details.
Event or Problem Description
It was reported that the instrument came apart during procedure and had to be retrieved by the surgeon.
Additional Manufacturer Narrative
(b)(4).Supplemental emdr.A physical sample was not available for investigation but bd was provided with two photos of the defect for evaluation.The first photo appeared to be a photo of the defect taken from a cell phone.The resolution and zoom were limited.It appeared that the device came apart into two pieces.The curette tip had separated from the shaft and handle.It appeared that the device was broken instead of coming apart, which leads to conclude that the weld around the curette tip end likely failed and the part that inserts onto the shaft loosened and came apart.It could not be verified in the photo if the sample tip was broken off or separated at the weld.The point of separation was observed at the distal working end, specifically at the point where the shaft transitions to the curette loop tip.Approximately half-inch to ¾ inch of the shaft remained on the tip, this may be the nipple part which inserts into the shaft¿s receptacle before it was welded.The second photo showed the device inside of a sterilization bag but the device was not clearly visible.Furthermore, the sample appeared to have several irregular slight bends in the shaft and more significant bends in the curette loop tip.The device was not marketed as malleable and it was unknown if the gl1625 product could be bent to suit user needs.Based on observations, it was likely that the sample was forcefully bent, intentional forces were applied to create the irregular bends, or the bending was a result of excessive forces or mechanical overstress.The sample appeared to have the correct overall shape per v.Mueller manufacturing specifications and possibly the correctly applied finishes.Upon zooming in, the picture resolution appeared blurred and pixelated, as a result, further details in the picture could not be observed and further sample v.Mueller manufactured authentication could not be performed.In conclusion, it was reported that the sample came apart while in use.Based solely on the information and photo observations, the sample may have failed due to a few different reasons.It could be due to excessive forces being applied to the distal working end, an aged, worn-down sample that was at end-of-life, and/or the sample was improperly maintained or lack thereof which caused the failure.For a more precise root cause the physical sample would have to be returned for investigation.H3 other text : device was not returned.Photos of defect were provided for investigation.
Event or Problem Description
It was reported that the instrument came apart during procedure and had to be retrieved by the surgeon.

• Brand Name: HUNTER LARGE UTERINE CURETTE 3CM BLD 8IN
• Common Device Name: CURETTE, UTERINE
• Manufacturer (Section D): CAREFUSION, INC; 5 sunnen drive; st. louis MO 63143
• MDR Report Key: 10870942
• Report Number: 1423507-2020-00058
• Device Sequence Number: 19455284
• Product Code: HCY
• UDI-Device Identifier: 10885403044748
• UDI-Public: (01)10885403044748
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: GL1625
• Device Catalogue Number: GL1625
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/06/2020
• Supplement Date Received by Manufacturer: 01/28/2021
• Initial Report FDA Received Date: 11/19/2020
• Supplement Report FDA Received Date: 01/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other