MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TUBE SET STERILE A127 PUMP; INSUFFLATOR, HYSTEROSCOPIC

Catalog Number T0449-01

Device Problem Pressure Problem (3012)

Patient Problem Swelling (2091)

Event Date 09/06/2018

Event Type  Injury  

Event Description

It was reported that the pump presented too much fluid causing that patients joint inflates.Customer tried to lower the pressure setting but it did not resolve the issue.Then, customer replaced the tubing and resumed the procedure.After, patient required an extra observation due to swelling of joint.

Manufacturer Narrative

Visual inspection and functional testing could not be performed because the device in question has not been returned for evaluation.Thus, the complaint could not be verified and a root cause could not be determined with confidence.It is difficult to perform an accurate evaluation of a failure without having the failed product to look at.As such the complaint is being closed without conclusion.However, if the product is returned in the future the complaint can be reopened and evaluated.A review of relevant clinical/medical information in the reported issue, inclusive of technique and patient information, to include, but not limited to: ·patient information ·surgical procedure/post-operative care review ·device labeling (including technique guides, ifus, etc.) insufficient clinically relevant documentation was provided; therefore a thorough medical investigation could not be performed.Per communication, a backup device/tubing was used to complete the shoulder procedure without surgical delay; however, due to shoulder joint and neck swelling the patient was admitted overnight for observation.The calibration cycle information, intra-op flow/pressure, if wash function was initiated, additional interventions, and current patient status remain unknown.Without evaluation of the tubing, unit, and/or clinically relevant documentation, the root cause of the reported event remains unknown.The patient impact was the possible additional radiological exposure, joint and neck swelling, and an overnight observation hospitalization.Should additional information become available, the clinical/medical task may be re-evaluated.Mimb review.Assess severity of complaint case to determine if additional actions or inputs are required for inclusion in the medical assessment.Determine if a medical assessment will be performed based on a review of the complaint details and further input from the medical director/designee.Complaint reviewed during mimb.A medical investigation will be performed.The device will not return for evaluation.Proceed based on information provided and/or available for the investigation; if no relevant clinical information is provided, recommend closure.Approved by medical doctor (b)(6) on (b)(6) 2018.Insufficient clinically relevant documentation was provided; therefore a thorough medical investigation could not be performed.Per communication, a backup device/tubing was used to complete the shoulder procedure without surgical delay; however, due to shoulder joint and neck swelling the patient was admitted overnight for observation.The calibration cycle information, intra-op flow/pressure, if wash function was initiated, additional interventions, and current patient status remain unknown.Without evaluation of the tubing, unit, and/or clinically relevant documentation, the root cause of the reported event remains unknown.The patient impact was the possible additional radiological exposure, joint and neck swelling, and an overnight observation hospitalization.Should additional information become available, the clinical/medical task may be re-evaluated.

• Brand Name: TUBE SET STERILE A127 PUMP
• Type of Device: INSUFFLATOR, HYSTEROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 7919134
• MDR Text Key: 122161224
• Report Number: 3003604053-2018-00154
• Device Sequence Number: 1
• Product Code: HIG
• Combination Product (y/n): N
• PMA/PMN Number: K031616
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: T0449-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/06/2018
• Initial Date FDA Received: 09/28/2018
• Supplement Dates Manufacturer Received: 09/25/2018; 11/06/2018
• Supplement Dates FDA Received: 10/03/2018; 11/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 60 YR
• Patient Weight: 68