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

Model Number 6003

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Cyst(s) (1800); Nausea (1970); Urinary Frequency (2275); Device Embedded In Tissue or Plaque (3165)

Event Date 11/03/2017

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical inc.Is currently investigating the complaint reported by plaintiff's counsel.Once the investigation is completed, a follow-up report will be filed.Reference: (b)(4).

Event Description

In connection with a personal injury lawsuit, it is alleged that on or about (b)(6) 2014, patient underwent a laparoscopic vaginal hysterectomy and bilateral salpingectomy, during which a surgical instrument, believed to be a kronner uterine manipulator, broke during surgery, which the surgeon and other employees of the facility failed to notice, resulting in the distal half of the instrument being left behind in the patient's abdomen.It is further alleged that in (b)(6) 2017, patient visited an urgent care facility for abdominal and back pain, nausea, and frequent urination.She followed up with her primary care physician who referred her to a urologist.The urologist performed a ct scan and identified a large mass in her abdomen by(b)(6) 2017.On (b)(6) 2017, patient underwent an emergent exploratory laparoscopy during which the distal half of a uterine manipulator injector system device was removed from her abdomen.During the (b)(6) 2017, surgery, significant adhesions and cysts were observed covering the area as a result of the fractured piece being left behind.It also is alleged that patient has required additional medical care and treatment.Ref: (b)(4).

Event Description

Report stated: "during the (b)(6) 2017 surgery, significant injuries were observed as a result of the foreign body, including but not limited to significant adhesions and cysts covering the area.Patient has required additional medical care and treatment, as well as additional surgery, to alleviate and mitigate the pain and injury".6003 kronner manipujector box (b)(4).

Manufacturer Narrative

Investigation: initiated manufacturer's investigation.No sample returned.Review dhr.Distribution history: the complaint product was purchased from bates industries.Manufacturing record review: a review of the device history record could not be performed because the lot number was not provided.However, it should be noted at the time of manufacture records from each lot are thoroughly reviewed to ensure that products are released meeting all coopersurgical quality release specifications.Should the complaint product lot number be provided going forward, the device history record will be reviewed, and this complaint amended accordingly.Incoming inspection review: a review of the incoming inspection record could not be performed because the complaint product lot number was not provided.Should the complaint product lot number be provided going forward, the incoming inspection report will be reviewed, and this complaint amended accordingly.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: root cause not applicable as the complaint condition was not confirmed.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: KRONNER MANIPUJECTOR BOX
• Type of Device: KRONNER MANIPUJECTOR BOX
• 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: 9512218
• MDR Text Key: 175188715
• Report Number: 1216677-2019-00318
• Device Sequence Number: 1
• Product Code: HES
• UDI-Device Identifier: 00888937015805
• UDI-Public: 888937015805
• 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: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6003
• Device Catalogue Number: 6003
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2019
• 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): Required Intervention; Other