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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOPERSURGICAL, INC. UTERINE MANIPULATOR TIP W
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COOPERSURGICAL, INC. UTERINE MANIPULATOR TIP W Back to Search Results
Model Number UMW676
Device Problem Material Perforation (2205)
Patient Problem Uterine Perforation (2121)
Event Date 06/06/2018
Event Type  malfunction  
Manufacturer Narrative
Coopersurgical, inc.Is currently investigating the reported condition.Once the investigation is complete, a follow up report wil be filed.(b)(4).
 
Event Description
"we had a rumi incident last week i thought i should call you about.It was a robotic hysterectomy with dr.(b)(6) and the rumi was placed by dr.(b)(6) after they were underway and then it was handled by a med student.During the case they noted something didn't look right and realized that the rumi tip (metal) had perforated the uterus and subsequently the sigmoid which had to be repaired by a general surgeon.The metal from the tip of the rumi had perforated through the balloon on the side about 1/2" from the tip and it wasn't noticed to be like that until it was in the bowel.Have you had any other incidents with the white tips, lot #224746? risk management has the actual tip.A psa was done.".
 
Manufacturer Narrative
Coopersurgical, inc.Is currently investigating the reported condition.Once the investigation is complete, a follow up report wil be filed.Reference e-complaint: (b)(4).09/27/2018 update: analysis and findings: the reported complaint is acknowledged; however, definitive root cause cannot be determined due to the affected device not being returned at the time of this investigative analysis.However, if the device is returned and made available, the complaint may be reopened and addressed as needed.By the event description the reported event may have occurred if excessive lateral force was applied thus enabling the metal support rod to penetrate the rumi tip.This may occur when the rod is in an acute angle in relation to the rumi tip with excessive force applied, pushing against the rumi tip wall from the inside - outward.Although not confirmed in this case that the rumi tip was improperly attached, the rumi tips-dfu instructs the user on how to properly attach the rumi tip to the handle.A review of the two-year product complaint history indicated no other complaint similar in nature.In conclusion, the result of this incident was likely attributed to improper loading, and or excessive or improper manipulation force by the end user.A review of the lot dhr did not reveal any abnormalities.Corrective actions: corrective action is not applicable as it is highly likely that this event was caused by improper use.All uterine manipulator products are 100% visually and functionally verified to be acceptable during manufacturing assembly.Reason: per bsr-qar-026, this complaint will be monitored for trending.Was the complaint confirmed? no.
 
Event Description
"we had a rumi incident last week i thought i should call you about.It was a robotic hysterectomy with dr.(b)(6) and the rumi was placed by dr.(b)(6) after they were underway and then it was handled by a med student.During the case they noted something didn't look right and realized that the rumi tip (metal) had perforated the uterus and subsequently the sigmoid which had to be repaired by a general surgeon.The metal from the tip of the rumi had perforated through the balloon on the side about 1/2" from the tip and it wasn't noticed to be like that until it was in the bowel.Have you had any other incidents with the white tips, lot #224746? risk management has the actual tip.A psa was done.".
 
Manufacturer Narrative
Investigation: initiated manufacturer's investigation no sample returned review dhr.Analysis and findings: the reported complaint is acknowledged; however, definitive root cause cannot be determined due to the affected device not being returned at the time of this investigative analysis.However, if the device is returned and made available, the complaint may be reopened and addressed as needed.By the event description the reported event may have occurred if excessive lateral force was applied thus enabling the metal support rod to penetrate the rumi tip.This may occur when the rod is in an acute angle in relation to the rumi tip with excessive force applied, pushing against the rumi tip wall from the inside - outward.Although not confirmed in this case that the rumi tip was improperly attached, the rumitips-dfu instructs the user on how to properly attach the rumi tip to the handle.A review of the two-year product complaint history indicated no other complaint similar in nature.In conclusion, the result of this incident was likely attributed to improper loading, and or excessive or improper manipulation force by the end user.A review of the lot dhr did not reveal any abnormalities.Correction and/or corrective action: corrective action is not applicable as it is highly likely that this event was caused by improper use.All uterine manipulator products are 100% visually and functionally verified to be acceptable during manufacturing assembly.Reason: this complaint will be monitored for trending.Was the complaint confirmed? no.
 
Event Description
We had a rumi incident last week i thought i should call you about.It was a robotic hysterectomy with dr.Munro and the rumi was placed by dr.Bruegl after they were underway and then it was handled by a med student.During the case they noted something didn't look right and realized that the rumi tip (metal) had perforated the uterus and subsequently the sigmoid which had to be repaired by a general surgeon.The metal from the tip of the rumi had perforated through the balloon on the side about 1/2" from the tip and it wasn't noticed to be like that until it was in the bowel.Have you had any other incidents with the white tips, lot #224746? risk management has the actual tip.A psa was done.6/26/18: medwatch mw5077882 received."the rumi manipulator plastic tip broke and metal poked through damaging the sigmoid colon in three areas requiring surgical intervention to repair the injury also resulting in prolonged admission.".
 
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Brand Name
UTERINE MANIPULATOR TIP W
Type of Device
UTERINE MANIPULATOR TIP W
Manufacturer (Section D)
COOPERSURGICAL, INC.
95 corporate drive
trumbull CT 06611
MDR Report Key7633898
MDR Text Key112177317
Report Number1216677-2018-00030
Device Sequence Number1
Product Code LKF
Combination Product (y/n)N
PMA/PMN Number
K932115
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup,Followup
Report Date 05/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/25/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/09/2020
Device Model NumberUMW676
Device Catalogue NumberUMW676
Device Lot Number231791
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received06/13/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
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