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

Model Number 6001

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Information (3190)

Event Date 08/09/2017

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical, inc.Is currently investigating the complaint condition.Once the investigation is complete, a follow up report wil be filed.(b)(4).

Event Description

Per medwatch ufi/importer report# (b)(4)."event desc: humi uterine manipulator was placed in vagina by physician.The physician then went to the abdomen to start the incision for laparoscopic port placement.Once ports were in place and the camera inserted into the abdomen via the ports, physician reached down to the vagina to use the manipulator.The uterus did not move around when he lifted up, but instead the plastic piece connected to the balloon snapped off.What was the original intended procedure? laparoscopic evacuation of the pelvic hematoma, partial salpingectomy.Device usage problem: device failed (e.G.Broke, couldn't get it to work or stopped working).".

Manufacturer Narrative

Coopersurgical, inc.Is currently investigating the complaint condition.Once the investigation is complete, a follow up report wil be filed.Reference e-complaint (b)(4).Update: 11/10/2017.Investigation: analysis and findings: the reported event that the "plastic piece connected to the balloon snapped" cannot be confirmed or verified due to the affected device sample not being returned at the time of this investigation.However, if the affected device is returned and made available in the future, the complaint may be reopened and addressed as needed.The humi-harris uterine manipulator is manufactured by an oem for csi trumbull.Without knowing how much force was applied to the device or what part of the device was affected a full analysis is not possible.It is likely that the device was used in a contraindicated manner per the device dfu.A review of the product two-year complaint history indicated that there have other reported events that are similar in nature while using the overall reported nonconforming state of the device as "broken".The device incorporates a reinforcement rib or handle in which the tube is snapped into, however, if the outer handle is dislodged the allowable max load may be compromised.Review of inventory stock for the reported lot indicated the lot was entirely depleted and no longer available.Corrective actions: corrective action is not applicable at this time due to the absence of the affected device, therefore a verification condition of the reported event, or a root cause cannot be determined.The nature of the reported event will be monitored for the feasibility of any further action.Reason: per (b)(4), this complaint will be monitored for trending in that no injury was reported to end user or patient.Was the complaint confirmed? no.

Event Description

Per medwatch ufi/importer report# (b)(4)."event desc: humi uterine manipulator was placed in vagina by physician.The physician then went to the abdomen to start the incision for laparoscopic port placement.Once ports were in place and the camera inserted into the abdomen via the ports, physician reached down to the vagina to use the manipulator.The uterus did not move around when he lifted up, but instead the plastic piece connected to the balloon snapped off.What was the original intended procedure? laparoscopic evacuation of the pelvic hematoma, partial salpingectomy.Device usage problem: device failed (e.G.Broke, couldn't get it to work or stopped working)".

• Brand Name: HUMI- HARRIS UTERINE MANI
• Type of Device: HUMI- HARRIS UTERINE MANI
• Manufacturer (Section D): COOPERSURGICAL, INC.; 75 corporate dr; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 75 corporate dr; trumbull CT 06611
• Manufacturer Contact: nana banafo ; 75 corporate dr; trumbull, CT 06611 ; 2036015200
• MDR Report Key: 6848212
• MDR Text Key: 85610977
• Report Number: 1216677-2017-00059
• 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
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 11/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/31/2018
• Device Model Number: 6001
• Device Catalogue Number: 6001
• Device Lot Number: 189118
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 28.0 YR
• Patient Weight: 79