MAUDE Adverse Event Report: COOPERSURGICAL, INC. ARCH KOH-EFFICIENT - UTERINE MANIPULATION; KOH-EFFICIENT,ARCH,3.5CM

Model Number KC-ARCH-35

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/31/2017

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical is currently investigating the reported conditoin.Once the investigation is complete, a follow up report will be filed.(b)(4).

Event Description

Per complainant: "we had an incident occur on friday (b)(6) with the rumi arch.The blue ring on the rumi arch broke off during a robotic case.The surgeon, (b)(6), was able to retrieve the blue ring by using a ring forcep to pull it out.No harm done to the patient." (b)(4).

Manufacturer Narrative

Coopersurgical is currently investigating the reported condition.Once the investigation is complete, a follow up report will be filed.Reference e-complaint-(b)(4).Update: investigation: analysis and findings: the returned products were still in packaging, though they are from the same lot as the complaint (lot# 207562).The actual unit with the cup pulling off was not returned for detailed root cause analysis, so a thorough investigation was not possible.The 6 samples were inspected, and placed through the qc inspection process of torque testing followed by a subsequent pull test, and all parts passed inspection.A dhr review was performed for kc-arch-35 with lot number 207562 and showed that all products were manufactured and tested per established procedures at csi stafford facility.Units was manufactured, assembled, inspected and tested per established procedures and there were no issues identified in the unit.The actual complaint unit was not returned for evaluation, so a conclusion on its mode of failure was indeterminable.However, during the validation of the glue, (using kc-arch-40), it was found that a glued unit is capable of withstanding an average of 171.25 pound force (lbf) with the lowest load at 81.51 lbf in eng-tst-10180.Additionally, another test was carried out to exert a side force on the assembly, done under eng-test-10181, showing that the unit is capable of withstanding an average side load of 68.62 lbf, with the lowest side load at 44.24 lbf.Corrective actions: 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?.

Event Description

Per complainant: "we had an incident occur on friday, march 31 with the rumi arch.The blue ring on the rumi arch broke off during a robotic case.The surgeon, dr.Bondurant, was able to retrieve the blue ring by using a ring forcep to pull it out.No harm done to the patient." reference e-complaint-(b)(4).

• Brand Name: ARCH KOH-EFFICIENT - UTERINE MANIPULATION
• Type of Device: KOH-EFFICIENT,ARCH,3.5CM
• 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: 6483435
• MDR Text Key: 72710725
• Report Number: 1216677-2017-00021
• Device Sequence Number: 1
• Product Code: HEW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K954311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/20/2017

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 Expiration Date: 06/06/2019
• Device Model Number: KC-ARCH-35
• Device Catalogue Number: KC-ARCH-35
• Device Lot Number: 207562
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/04/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/01/2016
• 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