MAUDE Adverse Event Report: COOPERSURGICAL, INC. R2015 RADIUS LOOP

Model Number R2015

Device Problem Failure to Cut (2587)

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

Event Date 04/04/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

"loop did not cut just charred edge of tissue.Had to change loops." "md frustrated due to char of tissue when margins are needed !" (b)(4).

Manufacturer Narrative

Investigation x-initiated manufacturer's investigation x-no sample returned analysis and findings e-complaint (b)(4).Was the complaint confirmed? no.The reported event cannot be physically verified as the device mentioned in the reported event was not returned.However, if the device is located and made available in the future, the complaint may be reopened and addressed as needed.Inventories of the affected lot could not be verified as the lot was reported as unknown.This device is oem manufactured for csi, sent for sterilization and distributed it from fg warehouse trumbull.Dhr review was not performed as the lot number was reported as "unknown".A review of the two-year product complaint history did not reveal further complaint info related to the reported event.Although the root cause is indeterminable its possible that that the device may have been used in contrary indicated manner in relation to proper size and or power output.Correction and/or corrective action corrective is not applicable due to the affected device not being available for investigative analysis at the time of this investigation, monitoring via complaint/ product surveillance will continue in order to identify any possible trend.This complaint will be monitored for trending in that no injury was reported to end user, or patient.Preventative action activity coopersurgical will continue to monitor this complaint condition for any trends.

Event Description

"loop did not cut just charred edge of tissue.Had to change loops." "md frustrated due to char of tissue when margins are needed !".Ref e-complaint (b)(4).

• Brand Name: R2015 RADIUS LOOP
• Type of Device: R2015 RADIUS LOOP
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer Contact: michael marone ; 50 corporate dr.; trumbull, CT 06611 ; 4752651665
• MDR Report Key: 8116908
• MDR Text Key: 128890976
• Report Number: 1216677-2018-00085
• Device Sequence Number: 1
• Product Code: HGI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K905747
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: R2015
• Device Catalogue Number: R2015
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/06/2018
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other