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

Model Number 6001

Device Problems Detachment of Device or Device Component (2907); Material Deformation (2976); Output Problem (3005)

Patient Problem Perforation of Vessels (2135)

Event Date 03/29/2022

Event Type  malfunction  

Manufacturer Narrative

The reported condition is currenlty being investigated.

Event Description

Incident details surrounding event dr.(b)(6) decided to use the humi since the kronner is on backorder.She ended up having some issues with it that i wanted you to be aware of.Dr.(b)(6) had told me that the humi is extremely hard and not flexible at all.The plastic "safeguard" piece that slides up and down on the manipulator would not budge at all and was very difficult to get back on.Once one side of the plastic piece was snapped on, the other end would not stay on very well.These issues caused the "safeguard" plastic piece to come off during the case and dr.(b)(6) ended up perforating this patient's uterus during a laparoscopic salpingectomy.1216677-2022-00104 humi- harris uterine mani 6001 e-complaint-(b)(4).

Event Description

Incident details surrounding event: dr.(b)(6) decided to use the humi since the kronner is on backorder.She ended up having some issues with it that i wanted you to be aware of.Dr.(b)(6) had told me that the humi is extremely hard and not flexible at all.The plastic "safeguard" piece that slides up and down on the manipulator would not budge at all and was very difficult to get back on.Once one side of the plastic piece was snapped on, the other end would not stay on very well.These issues caused the "safeguard" plastic piece to come off during the case and dr.(b)(6) ended up perforating this patient's uterus during a laparoscopic salpingectomy.1216677-2022-00104-1.Humi- harris uterine mani 6001.E-complaint-(b)(4).

Manufacturer Narrative

Investigation: no sample returned.Review dhr.Analysis and findings complaint (b)(4).Distribution history: this complaint unit was manufactured at csi on 10/21/2021 under wo # (b)(4) and shipped on 01/19/2022.Manufacturing record review: (b)(4) was reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review: (b)(4) lot numbers m20802 and m20772 were reviewed and no non-conformities, related to the complaint condition, were noted.Service history record: service history not applicable for this product.Historical complaint review: a review of the 2-year complaint history did not show similar reported complaint conditions.Product receipt: the complaint product has not been returned to coopersurgical.Visual evaluation: evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.If the product should be returned at a later date, it will be evaluated, and any findings will be appended to this investigation.Functional evaluation: evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.If the product should be returned at a later date, it will be evaluated, and any findings will be appended to this investigation.There is no inventory of lot number 309736 to test.Root cause: root cause not applicable as the complaint condition was not confirmed.There was no product returned for evaluation.If further information becomes available at a later date this investigation will be amended accordingly.Definitive root cause is indeterminable.Corrective actions: coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary, as the complaint condition was not confirmed.No further training required at this time.Was the complaint confirmed? no.

• 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.; 95 corporate drive; trumbull CT 06611
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, CT 06611 ; 4752651665
• MDR Report Key: 14073232
• MDR Text Key: 294600596
• Report Number: 1216677-2022-00104
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/02/2022

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 Operator: Health Professional
• Device Model Number: 6001
• Device Catalogue Number: 6001
• Device Lot Number: 309736
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/29/2022
• Initial Date FDA Received: 04/11/2022
• Supplement Dates Manufacturer Received: 03/29/2022
• Supplement Dates FDA Received: 06/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other