MAUDE Adverse Event Report: COOPERSURGICAL, INC. KOH-EFFICIENT,ARCH,4.0CM

Model Number KC-ARCH-40

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Discomfort (2330)

Event Date 11/23/2018

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

"dr.(b)(6) performed a lsh on a patient using a rumi koh 4.0 in march.She skipped her follow up appointment and then came in last week complaining of a smell and discomfort.Dr.(b)(6) couldn't take what he thought looked like a rumi cup out without causing the patient pain.They had booked an appointment for (b)(6) 2018 to remove the object, but it fell out on friday (b)(6).She came in to get checked out on (b)(6) and everything looked good.He said he found a small piece of what looked like a thick glove.He doesn't think it looks like a piece of the occluder balloon.He showed the patient a picture of the koh efficient and she didn't think that was it.She asked dr.(b)(6) about suing.She showed him a picture of the object that fell out and he said it didn't look like the koh efficient but maybe a piece of the koh efficient.I showed him a koh efficient and let him rip it apart.He doesn't see anything on the koh efficient that looks like the picture she showed him.He just doesn't know what else could be a cooper blue plastic that would be in her vagina.She was going to drop of the object but has not yet." (b)(4).

Manufacturer Narrative

Reference (b)(4).Investigation: x-initiated manufacturer's investigation; x-no sample returned ; x-review dhr.Analysis and findings: no product was returned for investigation.Complaint was created 11/28/18, and assigned on 4/16/19 and product was not returned.Additionally, the product lot number was not provided for dhr review.Details of the complaint is unclear as to whether or not the complaint condition was part of the kc-rumi, and it is unconfirmable by coopersurgical as no picture was provided for verification.A 2 year complaint history review for the product was performed and did not see other complaints similar to the complaint condition.Root cause for complaint condition cannot be determined from the information available.Although a dhr review was not possible, a 2 year shipment report was generated that lists previously shipped p/n kc-rumi-40 to the customer.The three most recent dhrs were reviewed (dhrs pertaining to lots 259715, 254107, and 233951) and found that there were no-nonconformances that relate to the complaint condition of a broken/deficient kc-rumi-40.Correction and/or corrective action: no product was returned for root cause analysis.No product returned for analysis.If product is returned in the future, pertinent information will be added to the complaint file.Complaint condition will be monitored for trending.Was the complaint confirmed? no.Preventative action activity: coopersurgical will continue to monitor this complaint condition for any trends.

Event Description

"dr.(b)(6) performed a lsh on a patient using a rumi koh 4.0 in (b)(6) 2018.She skipped her follow up appointment and then came in last week complaining of a smell and discomfort.Dr.(b)(6) couldn't take what he thought looked like a rumi cup out without causing the patient pain.They had booked an appointment for (b)(6) 2018 to remove the object, but it fell out on friday (b)(6) 2018.She came in to get checked out on (b)(6) 2018 and everything looked good.He said he found a small piece of what looked like a thick glove.He doesn't think it looks like a piece of the occluder balloon.He showed the patient a picture of the koh efficient and she didn't think that was it.She asked dr.(b)(6) about suing.She showed him a picture of the object that fell out and he said it didn't look like the koh efficient but maybe a piece of the koh efficient.I showed him a koh efficient and let him rip it apart.He doesn't see anything on the koh efficient that looks like the picture she showed him.He just doesn't know what else could be a cooper blue plastic that would be in her vagina.She was going to drop of the object but has not yet." ref (b)(4).

• Brand Name: KOH-EFFICIENT,ARCH,4.0CM
• Type of Device: KOH-EFFICIENT,ARCH,4.0CM
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• MDR Report Key: 8174608
• MDR Text Key: 131744419
• Report Number: 1216677-2018-00086
• Device Sequence Number: 1
• Product Code: HEW
• Combination Product (y/n): N
• PMA/PMN Number: K954311
• 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: 12/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: KC-ARCH-40
• Device Catalogue Number: KC-ARCH-40
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other