MAUDE Adverse Event Report: INTEGRA YORK, PA INC. ELEVATOR 3714383 GORNEY SUCTION 3MM TIP; PFM11

Catalog Number 3714383

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/19/2021

Event Type  malfunction  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A facility reported that the tip of the elevator gorney suction (3714383) broke during use.There was no patient injury or surgical delay reported.

Manufacturer Narrative

The elevator gorney suction (3714383) was not returned for evaluation; however, evaluation was performed per provided images as follows: the reported complaint was confirmed.Per the provided images, the elevator was in used condition with the end broken due to rough handling or environmental damage.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.

Event Description

N/a.

• Brand Name: ELEVATOR 3714383 GORNEY SUCTION 3MM TIP
• Type of Device: PFM11
• Manufacturer (Section D): INTEGRA YORK, PA INC.; 589 davies drive; 589 davies drive; york PA
• MDR Report Key: 11838064
• MDR Text Key: 256816973
• Report Number: 2523190-2021-00093
• Device Sequence Number: 1
• Product Code: KAD
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3714383
• Device Lot Number: BZ2009
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1