MAUDE Adverse Event Report: COOPERSURGICAL, INC. RUMI

Model Number UNKNOWN

Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical inc., is currently investigating the complaint condition reported.Once the investigation is completed a follow up report will be filed.(b)(4).

Event Description

Uf/importer report number (b)(6)."title : xxxxx event desc: the tip of a rumi uterine manipulator was inadvertently sutured to the cervix and broke off upon attempted removal ; this left the tip loose in the uterus.Operative hysteroscopy with retrieval of rumi tip was performed.This was a fault of the rumi cup and has not happened in the past.No identifying data available for the device, and it was not retained.Device usage problem: device failed.(e.G.Broke, couldn't get it to work or stopped working).Brand name rumi; common device name cannula, manipulator/injector, uterine ; product code unk " (b)(4).

Manufacturer Narrative

(b)(4) investigation: initiated manufacturer's investigation, no sample returned, review dhr, inspect returned samples, inspect stock product, *analysis and findings: no samples were sent back, nor were any serial numbers provided.However, from the information provided, the customer was dr.P phillips hospital - orlando regional health care.A shipping history record of products shipped to orlando regional health care was investigated and found that for the 2015 year, kc-rumi 30, kc-rumi-35, and kc-rumi-40 were shipped to orlando health.The lot numbers shipped were as follows: kc-rumi-30 [183966, 193743, 194879], kc-rumi-35 [189948, 192322, 194579], kc-rumi-40 [194398].A dhr review for all these identified lots was reviewed, all of which were delivered to customer in year 2015, and showed that all products were manufactured and tested per established procedures at lone star.All assemblies met the 10 lbf minimum pull-force specification.Additionally, a random sample of five from the work order was inspected by qc, also subjecting the assemblies to the functional pull test of 10 lbf minimum pull force, and none were rejected.A review of the cup and hinge drawing specifications was performed with no issues observed.Complaint mentions that cup had come off.However, since no samples were returned, a root cause was not determined.Similar complaints of the cup coming off the rumi assembly have been attributed to a compromised glue bond , although all parts have passed the pull test during the 100% inspection.As a result of this investigation, a new test was implemented that will test the assemblies at to a more stringent inspection.The new test involves a bending moment tester that will test all assemblies to (b)(4).This new bending moment test has been validated via (b)(4).Corrective actions: *correction and/or corrective action: as a corrective action, csi stafford has implemented a more stringent test via the implementation of a bending moment test, testing each of the rumi assemblies at 12-13 in-lbs during in process inspection, subsequently followed by a 10 lbf functional pull test.Additionally, qc will also perform the bending moment test (10-11 in lbs) followed by a 10-lbf functional pull test, with a raised aql level, equating to an increase of number of unit from 5 rumi assemblies, to 20 rumi assemblies.*corrective action level 2: train personnel, none, reason: *was the complaint confirmed? yes.Review and closure: recommended continuous improvement program (cip), capa required? #: complaint closure letter required? ncmr issued? #: other regulatory action needed: *preventative action activity: reviewed.Trend and monitor to cip.

Event Description

(b)(4)."title : xxxxx event desc: the tip of a rumi uterine manipulator was inadvertently sutured to the cervix and broke off upon attempted removal ; this left the tip loose in the uterus.Operative hysteroscopy with retrieval of rumi tip was performed.This was a fault of the rumi cup and has not happened in the past.No identifying data available for the device, and it was not retained.Device usage problem: device failed.(e.G.Broke, couldn't get it to work or stopped working).Brand name rumi.Common device name: cannula, manipulator/injector, uterine.Product code: unk " (b)(4).

• Brand Name: RUMI
• Type of Device: RUMI
• Manufacturer (Section D): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; product surveillance; 75 corporate drive; trumbull CT 06611
• Manufacturer Contact: nana banafo ; 75 corporate drive; trumbull, CT 06611 ; 2036015200
• MDR Report Key: 6131874
• MDR Text Key: 61315747
• Report Number: 1216677-2016-00065
• Device Sequence Number: 1
• Product Code: LKF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOIWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other