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

Model Number AD750SC-KE30

Device Problem Thermal Decomposition of Device (1071)

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

Event Date 05/06/2020

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical, inc.Is currently investigating the reported complaint condition.Reference: (b)(4).

Event Description

Complaint submitted by csi rep on behalf on account-" spatula was burning and scoring the colpotomy cup".Further stated- "pictures saved, the device in a biohazard bag and it resides in the coordinators office as of this email".Ref (b)(4).Sterile 3-0 soft koh-eff ad750sc-ke30 (b)(4).

Manufacturer Narrative

Reference: e-complaint (b)(4).Investigation: initiated manufacturer's investigation.No sample returned.Review dhr.Analysis and findings: distribution history: the complaint product was manufactured at csi on 11/06/19 under work order (b)(4).Manuf.Record review: dhr - 278824 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 hist.Record: service history record not applicable to this product.Historical complaint review: a review of the 2-year complaint history showed similar reported complaint conditions, where parts of the cup were becoming either damaged or melted.Product receipt: the complaint product has not been returned to coopersurgical.There is currently no rma for the product.Visual eval: evaluation of the complaint product could not be completed as the complaint product has not been returned.If the product should be returned at a later date, it will be evaluated, and any findings will be appended to this investigation.Complaint condition confirmed via pictures provided.Functional evaluation: evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.However, the complaint similar to other complaints as mentioned earlier.Quality engineering, research and development, marketing, and product surveillance conducted an investigation into 4 advincula soft koh-efficient product complaints (b)(4) from kaiser, where small fragments (~1mm) of the soft cup either became damaged or melted, disengaging from the cup.Root cause: the root cause of this issue has been attributed to a 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 : coopersurgical is exploring other potential soft materials with a higher melting temperature.Preventative action activity: reference capa 722.

Event Description

Complaint submitted by csi rep on behalf on account-" spatula was burning and scoring the colpotomy cup".Further stated- "pictures saved, the device in a biohazard bag and it resides in the coordinators office as of this email".Ref e-complaint (b)(4).1216677-2020-00120 sterile 3-0 soft koh-eff ad750sc-ke30 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
• MDR Report Key: 10059032
• MDR Text Key: 191394151
• Report Number: 1216677-2020-00120
• 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: 06/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 11/06/2020
• Device Model Number: AD750SC-KE30
• Device Catalogue Number: AD750SC-KE30
• Device Lot Number: 278824
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other