MAUDE Adverse Event Report: COOPERSURGICAL, INC. RUMI II

Model Number RUMI II

Device Problems Break (1069); Component Missing (2306)

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

Event Date 05/19/2021

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical , inc.Is currently investigating the condition reported on mw5101570.

Event Description

Per mw5101570 this patient was having a robotic assisted hysterectomy and at the end of the procedure when removing the uterus, the uterine manipulator was visualized to be broken.An x-ray of the abdomen and pelvis completed without a metal foreign body reported by the radiologist.No harm to patient.1216677-2021-00147 rumi ii mw5101570 (b)(4).

Manufacturer Narrative

Investigation: initiated manufacturer's investigation: no sample returned.Analysis and findings: distr.History: a distribution history record review was not possible for this product as the product type nor a lot number was provided for investigation manufacturer.Record review: a dhr review was not possible as a lot number was not provided.Incoming inspect.Review: incoming inspection record review not applicable to this product.Serv.Hist.Record: no service history record found for this unit.Historical complaint review: a 2 year historical complaint review was not possible because the product code/name identified in the complaint (rumi ii) is not a specific product, but a system of products.Product receipt: the complaint product has not been returned to coopersurgical.Visual eval.: 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 eval.: evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.Root cause: no definitive root cause for this issue could be reliably determined at this time, as the product was not returned for evaluation, nor information such as the product size or lot number was provided.Correction and/or corrective action: coopersurgical will continue to monitor this complaint condition for trends.No further training required at this time.Was the complaint confirmed? no.

Event Description

Per mw5101570.This patient was having a robotic assisted hysterectomy and at the end of the procedure when removing the uterus, the uterine manipulator was visualized to be broken.An x-ray of the abdomen and pelvis completed without a metal foreign body reported by the radiologist.No harm to patient.1216677-2021-00147-1.Rumi ii e-complaint #(b)(4).

• Brand Name: RUMI II
• Type of Device: RUMI II
• 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: 12222818
• MDR Text Key: 265393967
• Report Number: 1216677-2021-00147
• Device Sequence Number: 1
• Product Code: HEW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K954311
• 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: 02/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RUMI II
• Device Catalogue Number: RUMI II
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/25/2021
• 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): Required Intervention; Other