MAUDE Adverse Event Report: COOPERSURGICAL, INC. KOH-EFFICIENT,RUMI,3.5CM

Model Number KC-RUMI-35

Device Problem Disassembly (1168)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/06/2016

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical inc.Is currently investigating the reported complaint condition.The actual device involved in the complaint will not be returned for evaluation by the customer.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 ; during a laparoscopic hysterectomy and salpingectomy, the rumi uterine manipulator came apart during use while inside the patient.At time of removal the cup portion was still inside the patient , and was found and removed.Upon inspection the device does not appear to be broken , but did come apart.No harm came to the patient, all pieces removed at conclusion of procedure.(b)(4).

Manufacturer Narrative

(b)(4).Investigation: x-initiated manufacturer's investigation; x-no sample returned; x-review dhr; inspect returned samples; inspect stock product/ analysis and findings: dhr review for product no.Kc-rumi-35 (koh-efficient, rumi 3.5 cm), lot no.204886 manufactured/tested during may 2016 shows that all products were manufactured and tested per established procedures at lone star.During this work order, the lot was placed on hold based on another complaint (see below) as a precautionary step.The work order proceeded, undergoing the normal 100% functional inspection via a pull test, and there were no rejections observed.All assemblies met the 10 lbf minimum pull-force specification.Additionally, an 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.No samples were returned, so a root cause was not determined.Cup coming off the rumi assembly is similar to another complaint ((b)(4)), where the cup coming off was attributed to a compromised glue bond.In this mentioned complaint, although all parts have passed the pull test during the 100% inspection, the returned unit had the glue bond compromised.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 12-13 in-lbf.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: review and closure.X-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

Uf/importer report number (b)(4).Title : xxxxx.Event desc ; during a laparoscopic hysterectomy and salpingectomy, the rumi uterine manipulator came apart during use while inside the patient.At time of removal the cup portion was still inside the patient , and was found and removed.Upon inspection, the device does not appear to be broken , but did come apart.No harm came to the patient, all pieces removed at conclusion of procedure.(b)(4).

Manufacturer Narrative

Reference e-complaint-(b)(4).Investigation: x-initiated manufacturer's investigation: x-no sample returned.X-review dhr.Inspect returned samples.Inspect stock product.Analysis and findings: dhr review for product no.Kc-rumi-35 (koh-efficient, rumi 3.5 cm), lot no.204886 manufactured/tested during may 2016 shows that all products were manufactured and tested per established procedures at (b)(4).During this work order the lot was placed on hold based on another complaint (see below) as a precautionary step.The work order proceeded, undergoing the normal 100% functional inspection via a pull test, and there were no rejections observed.All assemblies met the 10 lbf minimum pull-force specification.Additionally, an 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.No samples were returned, so a root cause was not determined.Cup coming off the rumi assembly is similar to another complaint (b)(4), where the cup coming off was attributed to a compromised glue bond.In this mentioned complaint, although all parts have passed the pull test during the 100% inspection, the returned unit had the glue bond compromised.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 12-13 in-lbf.This new bending moment test has been validated via (b)(4).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: review and closure: x-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

Uf/importer report number (b)(4).Title : xxxxx.Event desc ; during a laparoscopic hysterectomy and salpingectomy, the rumi uterine manipulator came apart during use while inside the patient.At time of removal the cup portion was still inside the patient , and was found and removed.Upon inspection the device does not appear to be broken , but did come apart.No harm came to the patient, all pieces removed at conclusion of procedure.E-complaint (b)(4).

• Brand Name: KOH-EFFICIENT,RUMI,3.5CM
• Type of Device: KOH-EFFICIENT,RUMI,3.5CM
• Manufacturer (Section D): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer Contact: nana banafo ; 75 corporate drive; trumbull, CT 06611 ; 2036015200
• MDR Report Key: 6131902
• MDR Text Key: 61301212
• Report Number: 1216677-2016-00071
• Device Sequence Number: 1
• Product Code: HEW
• 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,Followup
• Report Date: 11/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/19/2019
• Device Model Number: KC-RUMI-35
• Device Catalogue Number: KC-RUMI-35
• Device Lot Number: 204886
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other