MAUDE Adverse Event Report: COVIDIEN 3631 LITE SLEEVE; LIGHT, SURGICAL, CEILING MOUNTED

Model Number 31140273

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/03/2020

Event Type  malfunction  

Manufacturer Narrative

The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.

Event Description

The customer reported the product is torn at the edge.

Manufacturer Narrative

The device history record (dhr) was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the reported issue described by the customer.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.A photograph was provided for evaluation.According to the photograph the issue was observed; the film and lite sleeve was broken.Two decontaminated samples were also received for evaluation and the reported condition was confirmed.The potential root cause is that the material was trapped during sealing time and caused a rupture in the package and the broken component.As part of continuous improvements, the following actions have been taken: a quality alert was made to notify to personnel of the issue reported by the customer of lite sleeve damage and broken; changed inspection level from normal to tightened; create standard work instruction under change.These actions are designed to prevent the reoccurrence of the reported damage.This complaint will be used for tracking and trending purposes.

• Brand Name: 3631 LITE SLEEVE
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 10534908
• MDR Text Key: 206963858
• Report Number: 9612030-2020-02611
• Device Sequence Number: 1
• Product Code: FSY
• UDI-Device Identifier: 20884527011596
• UDI-Public: 20884527011596
• Combination Product (y/n): N
• 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: 11/02/2020

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: 31140273
• Device Catalogue Number: 31140273
• Device Lot Number: 2002118464
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/04/2020
• Initial Date FDA Received: 09/15/2020
• Supplement Dates Manufacturer Received: 09/04/2020
• Supplement Dates FDA Received: 11/02/2020
• Patient Sequence Number: 1