MAUDE Adverse Event Report: MEDTRONIC PERFUSION SYSTEMS OCTOBASE SUTURE INSERT; RETRACTOR

Model Number 28707

Device Problem Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2017

Event Type  malfunction  

Manufacturer Narrative

Medtronic is unable to confirm or deny the complaint at the current time without the return of the product.

Event Description

Medtronic received information that when the customer inserted the suture holder into the octobase retractor, they noticed that a cam was missing.The patient¿s body was examined by x-ray, but the part was not located.The customer searched the operating room, operating table and trash but they were unable to locate the missing part.The customer continued to use the suture holder.There were no adverse patient effects reported.

Manufacturer Narrative

Product analysis: visual analysis of the returned device shows that one of the cams is missing from the suture holder insert.Conclusion: the complaint of a missing suture cam was confirmed.Review of the device history record found no record of abnormalities during manufacturing that would cause or contribute to the reported event.It could not be verified whether the cam was present in the insert when it was received by the customer.Medtronic will continue to monitor for future occurrences and trends.If information is provided in the future, a supplemental report will be issued.

• Brand Name: OCTOBASE SUTURE INSERT
• Type of Device: RETRACTOR
• Manufacturer (Section D): MEDTRONIC PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer (Section G): MEDTRONIC PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 7142359
• MDR Text Key: 95924909
• Report Number: 2184009-2017-00048
• Device Sequence Number: 1
• Product Code: GAD
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: 28707
• Device Catalogue Number: 28707
• Device Lot Number: 2017070388
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1