MAUDE Adverse Event Report: COOPERSURGICAL, INC. LEEP VU-MAX GRAVES LARGE

Model Number F219

Device Problem Naturally Worn (2988)

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

Event Date 05/24/2019

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

Customer stated "worn coating".Reference repair order: 92081.(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 no complaints for this issue.The lot number provided shows the instrument was packaged at coopersurgical prior to 2014.The returned instrument was reviewed by the service and repair department (repair order (b)(4)) and found to have worn coating.It is suspected the worn coating is due to normal wear of the instrument.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

Customer stated "worn coating".Reference repair order: (b)(4).Reference: (b)(4).

• Brand Name: LEEP VU-MAX GRAVES LARGE
• Type of Device: LEEP VU-MAX GRAVES LARGE
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• MDR Report Key: 8736505
• MDR Text Key: 149339928
• Report Number: 1216677-2019-00181
• 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: 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: F219
• Device Catalogue Number: F2219
• Device Lot Number: 0610028
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other