MAUDE Adverse Event Report: INTEGRA YORK, PA INC. COHEN INTRAUTERINE PROBE; N/A

Catalog Number 505230

Device Problems Use of Device Problem (1670); Device Dislodged or Dislocated (2923)

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

Event Date 12/29/2015

Event Type  malfunction  

Manufacturer Narrative

To date the device involved in the reported incident has not been received for evaluation.An investigation has been initiated based on the reported information.

Event Description

Customer initially reports that during her laparoscopic ovarian cystectomy the uterine manipulator was removed and the acorn was retained.On (b)(6) 2016 customer reports the acorn fell out of the vagina 2 days after procedure, no harm done.

Manufacturer Narrative

Integra has completed their internal investigation on 05/03/2016.The investigation included: methods: evaluation of actual device.Review of device history records.Results: the returned acorn showing wear and residue within the opening of the acorn.Upon visually inspecting the instrument, it is noticed that there is residue within the opening of the acorn.To test; the acorn was attached to a new probe and held as designed, there were no signs of looseness.Without knowing how the instrument was handled and maintained during use, the complaint report is undetermined.The instrument will be sent to the supplier as a supplier notification.Dhr review was completed with all history available.Nonconforming product report / nonconforming material report history: none.Variance authorization / deviation history: none.Engineering change order/manufacturing change order history: there is no applicable engineering change order/manufacturing change order history.Conclusion: there was acorn cannula, returned used/processed showing wear and residue within the opening of the acorn.The complaint report has been confirmed; the root cause has not been identified as a workmanship or material deficiency.

• Brand Name: COHEN INTRAUTERINE PROBE
• Type of Device: N/A
• Manufacturer (Section D): INTEGRA YORK, PA INC.; 589 davies drive; 589 davies drive; york PA 17402
• Manufacturer (Section G): INTEGRA YORK, PA INC.; 589 davies drive; york PA 17402
• Manufacturer Contact: sandra lee ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5550075
• MDR Text Key: 41960890
• Report Number: 2523190-2016-00053
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• PMA/PMN Number: K062033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/11/2016

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: Health Professional
• Device Catalogue Number: 505230
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/11/2016
• Initial Date FDA Received: 04/06/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 22 YR