MAUDE Adverse Event Report: COOPERSURGICAL, INC. KRONNER MANIPUJECTOR BOX

Model Number 6003

Device Problem Use of Device Problem (1670)

Patient Problem Hematoma (1884)

Event Date 09/03/2021

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical, inc ois currently investigating the reported condition.

Event Description

Incident details surrounding event: uterine manipulator was advanced into the uterus to provide a means of uterine manipulation during the surgery.Attention was then turned to the patient's abdomen.Upon entering the abdomen, a hematoma in the left pelvis was noted and found that the balloon from the uterine manipulator appeared to be outside the uterus but extraperitoneal.The balloon from the manipulator was slowly deflated and gently with drawn.There were no perforation and peritoneal defects in the pelvis.The hematoma was not expanding.Upon further research, it was felt to be a misuse of the product, not a malfunction.No initial findings of a recall for that lot number, but can you confirm? patient status stable.Patient was treated prophylactically and has done well.No further issues or complaints at time of follow up appointment.Kronner manipujector box 6003 e-complaint- (b)(4).

Event Description

Incident details surrounding event uterine manipulator was advanced into the uterus to provide a means of uterine manipulation during the surgery.Attention was then turned to the patient's abdomen.Upon entering the abdomen, a hematoma in the left pelvis was noted and found that the balloon from the uterine manipulator appeared to be outside the uterus but extraperitoneal.The balloon from the manipulator was slowly deflated and gently with drawn.There were no perforation and peritoneal defects in the pelvis.The hematoma was not expanding.Upon further research, it was felt to be a misuse of the product, not a malfunction.No initial findings of a recall for that lot number, but can you confirm? patient status stable.Patient was treated prophylactically and has done well.No further issues or complaints at time of follow up appointment.1216677-2021-00274 kronner manipujector box 6003 e-complaint-(b)(6).

Manufacturer Narrative

Investigation x-no sample returned x-review dhr *analysis and findings distribution history the complaint product was purchased from a supplier (bates industries) and packaged by csi under work order 265266 in september 2019.Manufacturing record review dhr-265266 was reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review incoming inspection record review not applicable to this product.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.Root cause no definitive root cause for this issue could be reliably determined at this time, however, as part of the reported complaint, it was suspected there was not a malfunction and there may have been misuse of the device.*correction and/or corrective action coopersurgical will continue to monitor this complaint condition for trends.*was the complaint confirmed? no.

• Brand Name: KRONNER MANIPUJECTOR BOX
• Type of Device: KRONNER
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 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: 12961772
• MDR Text Key: 283488064
• Report Number: 1216677-2021-00274
• Device Sequence Number: 1
• Product Code: HES
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K904473
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6003
• Device Catalogue Number: 6003
• Device Lot Number: 265266
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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