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 11/04/2018

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

Customer states on (b)(6) 2018 their was melting of koh soft cup during colpotomy.Doctor was able to remove all pieces from the patient nothing was left in the patient.(b)(4).

Manufacturer Narrative

*investigation x-initiated manufacturer's investigation x-no sample returned x-review dhr *analysis and findings 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.A review of complaints indicated that there were four similar complaints on file for this reported condition.A review of the device history record for lot no.227-18 and 222-18 indicated that the units were released meeting all quality release specifications at the time of manufacture and did not reveal any abnormalities.A review of the photographs received 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.*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-2018-11-0000113 re: subject report number: 3600270000-2019-8004.

Event Description

Customer states on (b)(6) 2018 their was melting of koh soft cup during colpotomy.Doctor was able to remove all pieces from the patient nothing was left in the patient.(b)(4).

Manufacturer Narrative

Investigation: x-initiated manufacturer's investigation, x-no sample returned and x-review dhr.Analysis and findings: 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 (~ 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.A review of complaints indicated that there were four similar complaints on file for this reported condition.A review of the device history record for lot no.227-18 and 222-18 indicated that the units were released meeting all quality release specifications at the time of manufacture and did not reveal any abnormalities.A review of the photographs received 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.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-2018-11-0000113 re: subject report number: 3600270000-2019-8004.

Event Description

Customer states on (b)(6) 2018 their was melting of koh soft cup during colpotomy.Doctor was able to remove all pieces from the patient nothing was left in the patient.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
• MDR Report Key: 8110225
• MDR Text Key: 128874771
• Report Number: 1216677-2018-00077
• 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,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 11/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2018
• 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?: No
• Date Manufacturer Received: 11/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other