MAUDE Adverse Event Report: COOPERSURGICAL, INC. LEEP GRAVES SPEC MED

Model Number 61514

Device Problem Material Fragmentation (1261)

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

Event Date 08/26/2019

Event Type  malfunction  

Manufacturer Narrative

The complaint condition reported is currently being investigated by coopersurgical, inc.

Event Description

The coating is chipping.Ref (b)(4).

Event Description

The coating is chipping.Ref e-complaint-(b)(4).

Manufacturer Narrative

E-complaint-(b)(4).Investigation: x-initiated manufacturer's investigation, x-inspect returned samples.Analysis and findings: distribution history, the complaint unit was purchased from murph industries.Manufacturing record review: not applicable to this product.Incoming inspection review: a review of the incoming inspection record could not be performed as the record could not be located at the time of this investigation.If the incoming inspection record should be located going forward, it will be reviewed, and this complaint amended accordingly.Service history record: service history not applicable for this product.Historical complaint review: a review of the attached 2-year complaint history showed 1 similar reported complaint condition where the product was reported for coating coming off.Product receipt: the complaint unit (leep graves spec med, qty: 1) was returned to the supplier on 09/20/2019.The lot number of the returned unit could not be determined.Visual evaluation: visual examination of the complaint unit revealed physical damage.The coating appeared to be cracked on the metal joint.Refer to the attached images.Functional evaluation: complaint unit/product was forwarded to supplier for analysis.Supplier confirmed the complaint.Per supplier analysis, no manufacturing defect found.The tube was most likely damaged in accidental mishap.Root cause: the root cause of the crack is attributed to improper handling by the end user.Correction and/or corrective action: coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary, as the complaint condition was not confirmed.Coopersurgical will continue to monitor this complaint condition for trends.Was the complaint confirmed? yes.

• Brand Name: LEEP GRAVES SPEC MED
• Type of Device: LEEP GRAVES SPEC MED
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• MDR Report Key: 9203577
• MDR Text Key: 191393952
• Report Number: 1216677-2019-00279
• 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: 12/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 61514
• Device Catalogue Number: 61514
• Device Lot Number: NONE
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other