MAUDE Adverse Event Report: COOPERSURGICAL, INC. RUMI II KOH-EFFICIENT; COLPOTOMY TUBE

Model Number KC-RUMI-35

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/12/2023

Event Type  Injury  

Manufacturer Narrative

G2: foreign: new zealand.Customer has indicated that the product was discarded.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that during a total laparoscopic hysterectomy case at (b)(6) hospital, a different size rumi koh was chosen and then inserted by the (b)(6) consultant.A rumi koh 3.5 was chosen for this case.At the end of the procedure vaginal bleeding was noted, when checked by surgeon a vaginal tear was noted on the one side and needed to be repaired.No additional information available.1216677-2023-00126 (b)(4).

Manufacturer Narrative

Distribution history: the complaint product was manufactured at csi on 06/07/2023 under work order (b)(4).Manufacturing record review: dhr 334174 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 record not applicable to this product.Historical complaint review: a review of the 2-year complaint history showed similar reported complaint conditions, however in those cases the complaint condition was not confirmed.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.Root cause: inventory balance was checked for lot 334174 and there was none left in stock for inspection.Complaints history for was reviewed to see if there were other complaints for lot 334174, and none were found.No definitive root cause for this issue could be reliably determined at this time, as the product was not returned for evaluation.It should be noted that the ifu of the device states that: using the sizer, determine the proper size of koh-efficient.A possible root cause of the failure may be attributed to the kc-sizer not being used as noted in the follow-up e-mail.Coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary, as the root cause cannot be reliably determined with the information provided.

Event Description

No additional information is available.

• Brand Name: RUMI II KOH-EFFICIENT
• Type of Device: COLPOTOMY TUBE
• 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 ; 50 corporate drive; trumbull, CT 06611 ; 4752651582
• MDR Report Key: 17775162
• MDR Text Key: 323750958
• Report Number: 1216677-2023-00126
• Device Sequence Number: 1
• Product Code: HEW
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K954311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: KC-RUMI-35
• Device Catalogue Number: KC-RUMI-35
• Device Lot Number: 334174
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2023
• 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): Required Intervention
• Patient Sex: Female