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

Model Number AD750SC-KE35

Device Problems Break (1069); Melted (1385)

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

Event Date 06/04/2019

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

Per rep's report over the telephone- "cup melted and broke off".(b)(4).

Manufacturer Narrative

Investigation: x-initiated manufacturer's investigation: x-no sample returned, x-review dhr.Analysis and findings: a review of the device history record for lot no.102-18 was made under wo 247148 indicated that the units were released meeting all quality release specifications at the time of manufacture and did not reveal any abnormalities.Although product was not returned, a complaint history review shows that there were other complaints that may be similar, with small fragments of the cups becoming either damaged or melted, disengaging from the cup.Quality engineering, research and development, marketing, and product surveillance conducted an investigation into other advincula soft koh-efficient product complaints ((b)(4)) from (b)(6), 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, 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 (b)(4).Was the complaint confirmed? no.Review and closure capa required? #: (b)(4).Preventative action activity reference capa (b)(4).Reference e-complaint (b)(4).Re: subject report number: 3600270000-2019-8004.

Event Description

Per rep's report over the telephone- "cup melted and broke off".Ref e-complaint (b)(4).

• 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
• Manufacturer (Section G): COOPERSURGICAL, INC,; 75 corporate drive; trumbull CT 06611
• Manufacturer Contact: peter niziolek ; 50 corporate drive; trumbull, CT 06611 ; 2036015200
• MDR Report Key: 8730890
• MDR Text Key: 150834828
• Report Number: 1216677-2019-00176
• Device Sequence Number: 1
• Product Code: HEW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180429
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other Health Care Professional
• 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: 06/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/11/2021
• Device Model Number: AD750SC-KE35
• Device Catalogue Number: AD750SC-KE35
• Device Lot Number: 102-18
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other