MAUDE Adverse Event Report: COOPERSURGICAL, INC. KOH-EFFICIENT,RUMI

Model Number KC-RUMI

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem Uterine Perforation (2121)

Event Date 01/01/2005

Event Type  Injury  

Manufacturer Narrative

Coopersurgical, inc.Is currently investigating the condition reported on mw5112764.

Event Description

Mw5112764.On what date did the complaint occur? (b)(4) 2005 *what are the details of the complaint? is there anything else? dear fda, the rumi uterus manipulator k954311 has a huge design mistake that could lead to misuse and rupture of the uterus.It was mentioned in a paper published in 2005.And i was surprised that in the product approval form that is submitted to you https://www.Accessdata.Fda.Gov/cdrh_docs/pdf/k954311.Pdf last page last paragraph "performance test" that the balloon can hold 250 cc, why? the uterus can hold 20-25 cc and will rupture.Two cases happened and documented in the literature https://pubmed.Ncbi.Nlm.Nih.Gov/15904626/ i call this device the uteru-destructor.It should be redesigned on the principles of poka-yoke whether to prevent the balloon to inflate that much or the line port connected to balloon should have warning label attached to it.I am sure hundred of women had this destructive experience all around the world.Please do something about it.Fda safety report id# (b)(4).From article: the rumi uterine manipulator is a useful device for uterine mobilization and chromopertubation during laparoscopic surgery.We report two cases of iatrogenic uterine rupture caused by overinflation of the intrauterine balloon of the rumi manipulator during chromopertubation.One rupture, which occurred on the uterine fundus, simply was sutured during surgery.Overinflation of the tip balloon of the rumi manipulator during chromopertubation can cause uterine rupture that can result in massive hematoma.What procedure was the physician performing? laparoscopic surgery.How is patient today? rupture was sutured during surgery.Did the physician perform any extra step to complete the procedure? sutured rupture closed.Rumi ii koh-efficient kc-rumi e-complaint-(b)(4).

Manufacturer Narrative

Investigation: no sample returned.*analysis and findings.Distribution history a distribution history record review was not possible for this product as the product type (kc-rumi-25,30 etc) nor a lot number was provided for investigation manufacturing record review a dhr review was not possible as a lot number was not provided.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 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.Functional evaluation 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.The complaint mentions that the uterus will rupture from "20-25cc" - though not confirmed, it should be noted that the rumi tip ifu (rumitip-b-dfu) mentions that the rumi tip balloon be inflated only with 3-5 cc of saline, not within the limit that the complaint states.Additionally, there appears to be a confusion between the different balloons on the kc-rumi-xx product.The kc-rumi product, fully assembled has two different balloons.There is the rumi tip balloon that is inserted into the uterus, and there is the occluder balloon that does not enter the uterus, and stays in the vagina.The rumi tip balloon cannot hold 250cc of water/saline, where as the occluder ifu gives instructions to inflate up to 120cc, nowhere near the 250cc mentioned.*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

Mw5112764 *on what date did the complaint occur? (b)(6) 2005.*what are the details of the complaint? is there anything else? dear fda, the rumi uterus manipulator k954311 has a huge design mistake that could lead to misuse and rupture of the uterus.It was mentioned in a paper published in 2005.And i was surprised that in the product approval form that is submitted to you https://www.Accessdata.Fda.Gov/cdrh_docs/pdf/k954311.Pdf last page last paragraph "performance test" that the balloon can hold 250 cc, why? the uterus can hold 20-25 cc and will rupture.Two cases happened and documented in the literature https://pubmed.Ncbi.Nlm.Nih.Gov/15904626/ i call this device the uteru-destructor.It should be redesigned on the principles of poka-yoke whether to prevent the balloon to inflate that much or the line port connected to balloon should have warning label attached to it.I am sure hundred of women had this destructive experience all around the world.Please do something about it.Fda safety report id# (b)(4).From article: the rumi uterine manipulator is a useful device for uterine mobilization and chromopertubation during laparoscopic surgery.We report two cases of iatrogenic uterine rupture caused by overinflation of the intrauterine balloon of the rumi manipulator during chromopertubation.One rupture, which occurred on the uterine fundus, simply was sutured during surgery.Overinflation of the tip balloon of the rumi manipulator during chromopertubation can cause uterine rupture that can result in massive hematoma.*what procedure was the physician performing? laparoscopic surgery.*how is patient today? rupture was sutured during surgery.*did the physician perform any extra step to complete the procedure? sutured rupture closed.1216677-2022-00291-1 rumi ii koh-efficient kc-rumi (b)(4).

• Brand Name: KOH-EFFICIENT,RUMI
• Type of Device: KOH-EFFICIENT,RUMI
• 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: 15722519
• MDR Text Key: 303026330
• Report Number: 1216677-2022-00291
• 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: Other,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: KC-RUMI
• Device Catalogue Number: KC-RUMI
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2022
• 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; Required Intervention