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 01/28/2019

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

Melting during use, (b)(6) 2018 @ 7:30 am.(b)(6).Delineator soft cup 3.0.(b)(4).

Event Description

Melting during use.December 20, 2018 @ 7:30 am, ucsf mb, san francisco, ca, dr.(b)(6), delineator soft cup 3.0.Ref (b)(4).

Manufacturer Narrative

Investigation: x-initiated manufacturer's investigation, x-no sample returned, x-review dhr.Analysis and findings: no product or lot number involved specifically to this complaint.However, the complaint pertains to the ad750sc-ke30, which are the soft cups advincula delineator.A 2 year complaint history shows that there are other similar complaints on files for the condition of melting cups.For those complaints, parts of the soft cups were melting.Quality engineering, research and development, marketing, and product surveillance conducted an investigation into 4 advincula soft koh-efficient product complaints (2018-11-0000113, 2018-11-0000117, 2018-11-0000120, & 2018-12-0000210) from kaiser, where small fragments (~ 1 mm) 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 file review, and photographs of the applied advincula soft koh-efficient products.In these aforementioned complaints, 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.Due to the complaint not being returned and no lot number was provided, a full investigation cannot be performed.Should complaint return in the future for evaluation, any pertinent information will be added to the complaint file.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 (b)(4).Re: subject report number: (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: 8355234
• MDR Text Key: 137687456
• Report Number: 1216677-2019-00032
• 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,health
• Type of Report: Initial,Followup
• Report Date: 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: AD750SC-KE30
• Device Catalogue Number: AD750SC-KE30
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other