MAUDE Adverse Event Report: COOPERSURGICAL, INC. KOH-EFFICIENT,ARCH,4.0CM

Model Number KC-ARCH-40

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/25/2020

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical , inc.Is currenlty investigating the condition reported.

Event Description

Report submitted by csi rep.Incident report: blue colpotomy part of koh cup separated during robotic total hysterectomy and was left remaining inside of patient.Colpotomy cup was recovered before case ended, and entire lot has been sequestered.Kc-arch-40 was opened for demonstration of event and also separated from the cup.(b)(4).

Manufacturer Narrative

Coopersurgical , inc.Is currently investigating the condition reported.

Event Description

Report submitted by csi rep.Incident report: blue colpotomy part of koh cup separated during robotic total hysterectomy and was left remaining inside of patient.Colpotomy cup was recovered before case ended, and entire lot has been sequestered.Kc-arch-40 was opened for demonstration of event and also separated from the cup.Ref: (b)(4).1216677-2020-00208 correction koh-efficient arch 4-0cm kc-arch-40 (b)(4).

Event Description

Incident report: blue colpotomy part of koh cup separated during robotic total hysterectomy and was left remaining inside of patient.Colpotomy cup was recovered before case ended, and entire lot has been sequestered.Kc-arch-40 was opened for demonstration of event and also separated from the cup.Koh-efficient arch 4-0cm kc-arch-40 e-complaint (b)(4).

Manufacturer Narrative

Investigation initiated manufacturer's investigation no sample returned review dhr.Analysis and findings distribution history the complaint product was manufactured at csi on 03/28/18 under work order (b)(4).Manufacturing record review dhr - 245618 was reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review incoming inspection record review not applicable to this product.Service history record service history record not applicable to this product.Historical complaint review a review of the 2-year complaint history did show similar reported complaint condition.Product receipt the complaint product has not been returned to coopersurgical.Visual evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.If the product should be returned at a later date, any findings will be appended to this investigation.An image was provided, but it pertained to a different lot and product size, therefore, complaint cannot be confirmed.Functional evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.If the unit/product should be returned at a later date, any pertinent findings will be appended to this investigation.Root cause no definitive root cause for this issue could be reliably determined at this time, since the product was not returned for investigation.With the information provided, a root cause analysis cannot be definitively performed.It is unknown if the customer used a sizer (kcp) to determine the proper size koh-efficient to use.This is listed under the dfu of the product (archkohadv-dfu).As a way of improving the manufacturing process, csi stafford has implemented 100% in process inspection of the product via bend testing and pull testing, followed by an aql qc inspection requiring the that the units also pass a bend and pull test.Correction and/or corrective action.Coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary, as the root cause cannot be reliably determined with the information provided.No further training required at this time.Was the complaint confirmed? no.

• Brand Name: KOH-EFFICIENT,ARCH,4.0CM
• Type of Device: KOH-EFFICIENT,ARCH,4.0CM
• Manufacturer (Section D): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, CT 06611 ; 4752651665
• MDR Report Key: 10523698
• MDR Text Key: 209154999
• Report Number: 1216677-2020-00208
• Device Sequence Number: 1
• Product Code: HEW
• UDI-Device Identifier: 00888937015171
• UDI-Public: 888937015171
• 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: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: KC-ARCH-40
• Device Catalogue Number: KC-ARCH-40
• Device Lot Number: 245618
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2018
• 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): Congenital Anomaly; Other