MAUDE Adverse Event Report: COOPERSURGICAL, INC. WEISMAN GRAVES NON CONDUCTIVE

Model Number 395-861

Device Problem Peeled/Delaminated (1454)

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

Event Date 06/18/2019

Event Type  malfunction  

Manufacturer Narrative

The complaint condition reported is currently under investigation.A follow - up report will be filed once the investigation has been completed and the findings are available.(b)(4).

Event Description

"conductive material has peeled off weisman graves specula open sided" reference repair order # (b)(4).(b)(4).

Event Description

"conductive material has peeled off weisman graves specula open sided".Reference repair order # (b)(4).Reference: (b)(4).

Manufacturer Narrative

Ref: (b)(4).*investigation: x-inspect returned samples.*analysis and findings: a review of the 2-year complaint history for the weisman graves non conductive speculum shows no similar complaints on file.This is an isolated event.The weisman graves non conductive speculum is a purchased product.Investigation of the returned product revealed chipped coating and the condition of the complaint was confirmed.This complaint condition is most likely an indicative of improper cleaning and/or sterilization of the instrument.Coopersurgical's service and repair replaced the instrument for customer due to the non-repairable damage.Reference repair order # (b)(4).Root cause is most likely attributed to improper care and maintenance by the customer.*correction and/or corrective action: no changes to the process or procedure.Coopersurgical will continue to monitor this complaint condition for any trends complaint will be reviewed in the coopersurgical cip (continuous improvement program) program.*was the complaint confirmed? yes.**preventative action activity: coopersurgical will continue to monitor this complaint condition for any trends.

• Brand Name: WEISMAN GRAVES NON CONDUCTIVE
• Type of Device: WEISMAN GRAVES NON CONDUCTIVE
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• MDR Report Key: 8799270
• MDR Text Key: 151562005
• Report Number: 1216677-2019-00205
• Device Sequence Number: 1
• Product Code: HDF
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 395-861
• Device Catalogue Number: 395-861
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/11/2019
• Initial Date FDA Received: 07/17/2019
• Supplement Dates Manufacturer Received: 07/11/2019
• Supplement Dates FDA Received: 12/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other