MAUDE Adverse Event Report: COOPERSURGICAL, INC. 5MM ELASTIC STAYS 8/PK

Model Number 3311-8G

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Tissue Damage (2104)

Event Date 03/27/2018

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical, inc.Is currently investigating the reported condition.Once the investigation is complete, a follow up report will be filed.(b)(4).

Event Description

"hooks tore through patients tissue requiring sutures to repair.Tore vaginal tissue causing three small tears that required sutures.Surgeon has photographic documentation of the event.".

Manufacturer Narrative

Coopersurgical, inc.Is currenty investigating the reported condition.Once the investigation is complete, a follow up report will be filed.(b)(4).Update 6/29/2018: investigation: analysis and findings; dhr review shows 3311-8g was made to wo-237118 in nov 2017 and was manufactured, assembled, inspected and tested per established procedures and there were no issues identified during the manufacture/in-process inspections.The lot is subjected to random aql sampling for qc test.During qc test, an aql sample size is taken from the lot and pull tested to 4 lbs, held for 60 seconds to ensure that there is no non-conformances.The complaint was not confirmed as the product was not returned for root cause investigation.The complaint entry mention that there were photograpnic evidence however, this was not provided when requested from the customer.Complaint entry mentions that the patient had "delicate/friable tissue by scrub team/surgeon" which may have attributed to the tearing of the vaginal wall.This may have been the cause of the tissue tear, as delicate tissue may be more prone to tear.A 4 year complaint history review for p/n 3311-8g did not have another occurrence of a tear of tissue.This may indicate to a usage error and not considered to be a manufacturing issue.Corrective actions: correction and/or corrective action; root cause not determined to be manufacturing defect.Complaint condition will be monitored for any developing trends.Reason: root cause not determined to be manufacturing issue.

Event Description

"hooks tore through patients tissue requiring sutures to repair.Tore vaginal tissue causing three small tears that required sutures.Surgeon has photographic documentation of the event.".

• Brand Name: 5MM ELASTIC STAYS 8/PK
• Type of Device: 5MM ELASTIC STAYS 8/PK
• Manufacturer (Section D): COOPERSURGICAL, INC.; 75 corporate dr; trumbull CT 06611
• MDR Report Key: 7423425
• MDR Text Key: 105386703
• Report Number: 1216677-2018-00016
• Device Sequence Number: 1
• Product Code: GAD
• Combination Product (y/n): N
• PMA/PMN Number: K791665
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 04/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/03/2022
• Device Model Number: 3311-8G
• Device Catalogue Number: 3311-8G
• Device Lot Number: 237118
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention