MAUDE Adverse Event Report: COOERSURGICAL INC. ARCH KOH-EFFICIENT; KC-ARCH

Catalog Number KC-ARCH-40

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/07/2013

Event Type  malfunction  

Event Description

As reported on medwatch form (mw5035729) - "a ring on a device to remove a uterus via robotic surgery broke off and was left on the patient's cervix.Reason for use was to assist in the removal of the uterus via robotic surgery.".

Manufacturer Narrative

(b)(4).The customer did not provide the lot number or return the actual product involved in the event.Dhr review for selected lots 122649, 126866, 140912, 154762, 154764, and 155273 show the products met all approved release specifications at the time of manufacture before they were released.There were no manufacturing issues during the manufacture of the lots.There have not been any related design or specification changes over the last two years.Sample product form finished goods (fg) was evaluated and the reported condition could not be duplicated.All products tested exceeded the minimum pull force specification of 10 lbs.The finished goods sampled meet all approved release specifications.There were no indications of nonconformance.A 1 year historical review of complaints shows 2 similar complaints within the same product family.The reported condition could not be confirmed as the actual sample was no returned.This complaint condition may be re-opened and re-evaluated if the sample becomes available.Similar past complaint investigations by quality engineering concluded the likely cause of the reported condition to be excessive force during use.Based on the evaluation and testing of finished goods (fg) samples, dhr review, and overall product knowledge, the likely cause of the reported complaint condition is excessive manipulation and force applied by the end user.Coopersurgical will continue to monitor the complaint condition for any trends.Note: this complaint appears to be duplicate to e-complaint 2014-04-0000033.

• Brand Name: ARCH KOH-EFFICIENT
• Type of Device: KC-ARCH
• Manufacturer (Section D): COOERSURGICAL INC.; trumbull CT
• Manufacturer Contact: nana banafo ; 75 corporate dr.; trumbull, CT 06611
• MDR Report Key: 4174972
• MDR Text Key: 15325912
• Report Number: 1627186-2014-00007
• Device Sequence Number: 1
• Product Code: LKF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Unknown
• Type of Report: Initial
• Report Date: 08/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: KC-ARCH-40
• Was Device Available for Evaluation?: No
• 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