MAUDE Adverse Event Report: COOPERSURGICAL, INC. STERILE 3.5 SOFT KOH-EFF

Model Number AD750SC-KE35

Device Problem Melted (1385)

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

Event Date 09/12/2018

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

(b)(4).Coopersurgical has determined the condition reported (on (b)(6) 2018) : "this was sample product that was used in a case this morning at medical city plano.Upon completion of the case, it was discovered that the cup had been damaged during colpotomy stage of procedure.Surgeon stayed superficial to tissue during colpotomy using mono-polar robotic scs, however melting/lacerations to cup must have occurred when sc tips made contact with cup.No patient injury, and nothing was deposited or left in patient." to be a reportable malfunction, based on the cumulative investigation of this failure mode on- (b)(6) 2019.

Manufacturer Narrative

Reference: (b)(4).Cumulative investigation of this failure mode concluded on 01/17/19.Analysis: quality engineering, research and development, marketing, and product surveillance conducted an investigation into the advincula soft koh-efficient product complaint (b)(4) from med.Center of plano, where small fragments of the soft cup either became damaged or melted, disengaging from the cup.This evaluation was based on a review of complaint history, a design history file review, and investigation of the returned advincula soft koh-efficient.A review of complaints indicated that there were seven similar complaints on file for this reported condition.A review of the device history record for lot no.227-18 indicated that the units were released meeting all quality release specifications at the time of manufacture and did not reveal any abnormalities.Investigation of the returned advincula soft koh-efficient confirmed the reported condition.Replication of the reported condition may be attributed to technique during a colpotomy, in which constant movement of the electrosurgical unit (esu) cutting tip is necessary.For example, if the end user does not keep the esu tip moving and remains in one place on tissue for an extended period of time, the advincula soft cup material may begin to melt.Coopersurgical will continue to monitor this complaint condition for any trends.

Event Description

Ref: (b)(4).Coopersurgical has determined the condition reported (on 9/17/2018) : "this was sample product that was used in a case this morning at medical city plano.Upon completion of the case, it was discovered that the cup had been damaged during colpotomy stage of procedure.Surgeon stayed superficial to tissue during colpotomy using mono-polar robotic scs, however melting/lacerations to cup must have occurred when sc tips made contact with cup.No patient injury, and nothing was deposited or left in patient." to be a reportable malfunction, based on the cumulative investigation of this failure mode on- 01/17/19.

• Brand Name: STERILE 3.5 SOFT KOH-EFF
• Type of Device: STERILE 3.5 SOFT KOH-EFF
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• MDR Report Key: 8311305
• MDR Text Key: 136994953
• Report Number: 1216677-2019-00016
• Device Sequence Number: 1
• Product Code: HEW
• Combination Product (y/n): N
• PMA/PMN Number: K180429
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 02/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 08/15/2021
• Device Model Number: AD750SC-KE35
• Device Catalogue Number: AD750SC-KE35
• Device Lot Number: 227-18
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other