MAUDE Adverse Event Report: COOPERSURGICAL, INC. HUMI- HARRIS UTERINE MANI

Model Number 6001

Device Problem Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 03/31/2022

Event Type  malfunction  

Event Description

The handle ejected forcefully and left behind the tip.The surgeon removed it and finished the procedure.The order# is 5918368.A ups label was sent.It was a robotic hysterectomy so definitely general anesthesia.I believe she used a grasper under direct visualization to remove the price.It's hard to say how long of a delay it caused, but i would assume less than 15 minutes.1216677-2022-00125 humi- harris uterine mani 6001 e-complaint-(b)(4).

Manufacturer Narrative

The reported condition is currenlty being investigated.

Event Description

The handle ejected forcefully and left behind the tip.The surgeon removed it and finished the procedure.The order# is 5918368.A ups label was sent.It was a robotic hysterectomy so definitely general anesthesia.I believe she used a grasper under direct visualization to remove the price.It's hard to say how long of a delay it caused, but i would assume less than 15 minutes.Humi- harris uterine mani 6001, e-complaint(b)(4).

Manufacturer Narrative

Investigation: x-review dhr: x-inspect returned samples.Analysis and findings: complaint (b)4).Distribution history: this complaint unit was manufactured at csi on 01/22/2021 under wo # 296894 and shipped on 02/16/2021.Manufacturing record review: dhr-296894 was reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review: iqc-52859 lot numbers m20381 and m20444 were received dock to stock, so no inspections were performed.Service history record: service history not applicable for this product.Historical complaint review: a review of the 2-year complaint history did show similar reported complaint conditions.Product receipt: the complaint product has been returned to coopersurgical.Visual evaluation: visual examination of the complaint product revealed no physical damage.Functional evaluation: complaint product was functionally evaluated and found to function properly.The unit was received with the removable rigid handle detached from the unit.The handle was reattached and the unit functioned properly.The balloon was inflated and held air and the irrigation port was able to expel liquids through the distal port.Root cause: there are several possible reasons for the handle becoming detached from the handle.Per the attached ifu (6001-ifu) step 13, excessive force or rapid insertion of liquid or gas could cause the expulsion of the unit.The unit could possibly have been mishandled by the user.Definitive root cause is indeterminable.Correction and/or corrective action / preventative action activity.Coopersurgical will continue to monitor this complaint condition for trends.

• Brand Name: HUMI- HARRIS UTERINE MANI
• Type of Device: HUMI- HARRIS UTERINE MANI
• Manufacturer (Section D): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer Contact: michael marone ; 75 corporate drive; trumbull, CT 06611 ; 4752651665
• MDR Report Key: 14251450
• MDR Text Key: 298710649
• Report Number: 1216677-2022-00125
• Device Sequence Number: 1
• Product Code: KNA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K770727
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/29/2022

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
• Device Model Number: 6001
• Device Catalogue Number: 6001
• Device Lot Number: 296894
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/31/2022
• Initial Date FDA Received: 04/29/2022
• Supplement Dates Manufacturer Received: 03/31/2022
• Supplement Dates FDA Received: 10/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other