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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOPERSURGICAL, INC. KOH-EFFICIENT,RUMI
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COOPERSURGICAL, INC. KOH-EFFICIENT,RUMI Back to Search Results
Model Number KC-RUMI
Device Problems Break (1069); Loose or Intermittent Connection (1371)
Patient Problem Bowel Perforation (2668)
Event Date 10/18/2019
Event Type  Injury  
Manufacturer Narrative
Ref: (b)(4).The rumi purchase history for this account showed a number of rumi handles (part number umh650) were purchased, as well as tips from sizes 25 - 40.Coopersurgical inc.Is currently investigating the complaint reported by plaintiff's counsel.Once the investigation is completed, a follow-up report will be filed.
 
Event Description
In connection with a personal injury lawsuit, it is alleged that on or about (b)(6) 2018, patient underwent a hysterectomy during which the surgeon is alleged to have used a surgical instrument, believed to be a kc-rumi manipulator.According to plaintiff's allegations, a bowel perforation developed as a result of the original hysterectomy surgery.Plaintiff is attributing the bowel perforation to the surgeon's "failing to perform the surgery properly and/or to check and/or discovery that the rumi manipulator was loose, broker or damaged and were negligent in using the manipulator." plaintiff has not produced evidence to support her allegations.We are in the process of gathering the surgical records and will supplement this report on additional information is known.Ref: (b)(4).
 
Manufacturer Narrative
(b)(6).The rumi purchase history for this account showed a number of rumi handles (part number umh650) were purchased, as well as tips from sizes 25 - 40.Ref: (b)(4).Investgation: x-initiated manufacturer's investigation, x-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 attached 2-year complaint history did not show similar reported complaint conditions.There were no prior complaint history where the product was involved in a bowel perforation.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: no definitive root cause for this issue could be reliably determined at this time, as the product was not returned for evaluation, nor were photographs provided, as well as no specific product size or lot number was provided.Correction and/or corrective action / *preventative action activity coopersurgical will continue to monitor this complaint condition for trends.
 
Event Description
In connection with a personal injury lawsuit, it is alleged that on or about (b)(6) 2018, patient underwent a hysterectomy during which the surgeon is alleged to have used a surgical instrument, believed to be a kc-rumi manipulator.According to plaintiff's allegations, a bowel perforation developed as a result of the original hysterectomy surgery.Plaintiff is attributing the bowel perforation to the surgeon's "failing to perform the surgery properly and/or to check and/or discovery that the rumi manipulator was loose, broker or damaged and were negligent in using the manipulator." plaintiff has not produced evidence to support her allegations.We are in the process of gathering the surgical records and will supplement this report on additional information is known.Ref: (b)(4).(b)(6).
 
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Brand Name
KOH-EFFICIENT,RUMI
Type of Device
KOH-EFFICIENT,RUMI
Manufacturer (Section D)
COOPERSURGICAL, INC.
95 corporate drive
trumbull, ct
MDR Report Key9713752
MDR Text Key192432294
Report Number1216677-2020-00025
Device Sequence Number1
Product Code HEW
Combination Product (y/n)N
PMA/PMN Number
K954311
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 05/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/14/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberKC-RUMI
Device Catalogue NumberKC-RUMI
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received01/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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