MAUDE Adverse Event Report: COOPERSURGICAL, INC. KOH-EFFICIENT,RUMI,3.5CM; RUMI II KOH-EFFICIENT - UTERINE MANIPULATOR

Model Number KC-RUMI-30 OR KC-RUMI-35

Device Problem Inflation Problem (1310)

Patient Problem Laceration(s) (1946)

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical inc.Is currently investigating the reported complaint condition.Once the investigation is complete, a follow up report will be filed.(b)(4).Device hasn't been returned yet.

Event Description

(b)(4)."the issue is that the balloons inflated in an irregular non congruent fashion and the surgeon believes that this may have caused the vaginal laceration." patient is unknown.

Manufacturer Narrative

Coopersurgical inc.Is currently investigating the reported complaint condition.Once the investgation is complete, a follow up report will be filed.Referance: e-complaint-(b)(4).Update: investigation: no sample returned.Analysis and findings: product is currently listed in complaints initiation page with rma # (b)(4), however, the parts has not arrived at csi for investigation.Additionally, there is no serial number provided, so a dhr review was not possible as it cannot be determined currently.A complaint history review was performed, and found another complaint (b)(4) with the unit returned for evaluation.Under the stated investigation, water inflation of the occluder balloon was performed to try to recreate the stated irregularity, resulting in the balloon showing no irregularities.The root cause was not determinable due to the absense of the objective evidence.Since the product has not arrived for investigation, this complaint will be closed.Should the unit arrive, this complaint investigation will be revisited if there are any new findings.As there is no clear indication of serial number of the returned product, a stock inventory check was not possible.Correction and/or corrective action: corrective action is not applicable at this time as the root cause was indeterminable due to the absence of the affected product sample.Reason: per (b)(4) this complaint will be monitored for trending in that no injury was reported to end user, or patient.Was the complaint confirmed? no.

Event Description

Referacne e-complaint-(b)(4)."the issue is that the balloons inflated in an irregular non congruent fashion and the surgeon believes that this may have caused the vaginal laceration." patient is unknown.

• Brand Name: KOH-EFFICIENT,RUMI,3.5CM
• Type of Device: RUMI II KOH-EFFICIENT - UTERINE MANIPULATOR
• Manufacturer (Section D): COOPERSURGICAL, INC.; 75 corporate dr; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 75 corporate dr; trumbull CT 06611
• Manufacturer Contact: nana banafo ; 75 corporate dr; trumbull, CT 06611 ; 2036015200
• MDR Report Key: 6482004
• MDR Text Key: 72791618
• Report Number: 1216677-2017-00020
• Device Sequence Number: 1
• Product Code: HEW
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K954311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: KC-RUMI-30 OR KC-RUMI-35
• Device Catalogue Number: KC-RUMI-30 OR KC-RUMI-35
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/04/2017
• 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