MAUDE Adverse Event Report: COOPERSURGICAL, INC. GRAVES SPECULUM MEDIUM

Model Number F205

Device Problem Defective Device (2588)

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

Event Date 06/10/2019

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

Per customer need for "re-coat", "noticed upon decontamination and inspection".Per customer need for "re-coat", "noticed upon decontamination and inspection".Reference repair order: (b)(4).

Manufacturer Narrative

Ref: (b)(4).*investigation: x-inspect returned samples.*analysis and findings: the returned instrument was sent back as a repair item.The instrument is coated by a sub-supplier and upon return to coopersurgical, each instrument is hi-pot tested to insure there is proper coating.A review of two year complaint history shows some complaints for this issue.The lot number (0105052) provided in the repair order shows this instrument was packaged at coopersurgical prior to 2014.The returned instrument was reviewed by the service and repair department (repair order 92168) and found to have a non-conformity in the coating.A definitive cause of the non-conformity could not be reliably determined at this time.Since this product is 100% inspected at coopersurgical, it is suspected it may have occurred either due to improper handling and/or damaging impact by the end user or due to normal wear.*correction and/or corrective action: the customer was sent a replacement instrument.Will continue to monitor for trending.*was the complaint confirmed? yes.*preventative action activity : coopersurgical will continue to monitor this complaint condition for any trends.

Event Description

Per customer need for "re-coat", "noticed upon decontamination and inspection".Reference repair order: (b)(4).Reference: (b)(4).

• Brand Name: GRAVES SPECULUM MEDIUM
• Type of Device: GRAVES SPECULUM MEDIUM
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• MDR Report Key: 8752893
• MDR Text Key: 150120854
• Report Number: 1216677-2019-00190
• Device Sequence Number: 1
• Product Code: HDF
• Combination Product (y/n): N
• PMA/PMN Number: K951898
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Remedial Action: Replace
• 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: F205
• Device Catalogue Number: F205
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/17/2019
• Initial Date FDA Received: 07/02/2019
• Supplement Dates Manufacturer Received: 07/17/2019
• 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