MAUDE Adverse Event Report: COOPERSURGICAL, INC. STERILE 3.0 SOFT KOH-EFF

Model Number AD750SC-KE30

Device Problem Melted (1385)

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

Event Date 05/17/2019

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

"the soft cup melted during the procedure." (b)(4).

Manufacturer Narrative

Reference: e-complaint-(b)(4).Investigation: x-initiated manufacturer's investigation, x-review dhr and x-inspect returned samples.Analysis and findings: a dhr review of lot number 264-18 indicates that the product was under dhr wo# (b)(4) for the ad750sc-ke30, and was made in oct 2018.Review of the dhr-ad750sc-ke30-252214 shows no nonconformities associated to this complaint.Quality engineering, research and development, marketing, and product surveillance conducted an investigation into the advincula soft koh-efficient product complaint (b)(4) from university of md ob/gyn, 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 device history record review, and investigation of returned advincula soft koh-efficient product from similar complaints.A review of complaints indicated that there were similar complaints on file for this reported condition.This complaint is confirmed based upon returned unit and its part of the parent investigation as indicated in capa 722.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.Correction and/or corrective action none.Reason: the product met the required release specifications per dhr review.No re-training required.Coopersurgical is exploring other potential soft materials with a higher melting temperature - reference capa 722.Was the complaint confirmed? yes.Review and closure: capa required? #: 722 preventative action activity: reference capa 722.Reference e-complaint-(b)(4).Re: subject report number: (b)(4).

Event Description

"the soft cup melted during the procedure." ref e-complaint-(b)(4).

• Brand Name: STERILE 3.0 SOFT KOH-EFF
• Type of Device: STERILE 3.0 SOFT KOH-EFF
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• MDR Report Key: 8649248
• MDR Text Key: 146358777
• Report Number: 1216677-2019-00094
• 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: 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/21/2021
• Device Model Number: AD750SC-KE30
• Device Catalogue Number: AD750SC-KE30
• Device Lot Number: 264-18
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other