MAUDE Adverse Event Report: GYRUS ACMI INC SHOCKPULSE LITHOTRIPSY TRANSDUCER.; LITHOTRIPTOR, ULTRASONIC

Model Number SPL-T

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Inflammation (1932)

Event Date 06/29/2017

Event Type  Injury  

Manufacturer Narrative

The device was not returned to olympus for evaluation.The cause of the reported event cannot be determined.If additional information becomes available at a later time, this report will be supplemented.

Event Description

The manufacturer received literature titled "interventional radiology-operated cholecystoscopy for the management of symptomatic cholelithiasis: approach, technical success, safety, and clinical outcomes".The objective of the study was to report the technique, complications, and clinical outcomes of interventional radiology¿operated cholecystoscopy with stone removal for the management of symptomatic cholelithiasis.Ten (77%) men and three (23%) women (mean age, 65 years) with symptomatic cholelithiasis underwent cholecystostomy followed by interventional radiology¿operated cholecystoscopy with stone removal.Major comorbidities precluding cholecystectomy included prior cardiac, pulmonary, or abdominal surgery; cirrhosis; sepsis with hyponatremia; seizure disorder; developmental delay; and cholecystoduodenal fistula.Cholecystostomy access, time between cholecystostomy and cholecystoscopy, endoscopic and fragmentation devices used, technical success, procedure time, fluoroscopy time, complications, length of hospital stay, time between cholecystoscopy and cholecystostomy removal, follow-up, and acute cholecystitis recurrence were recorded.The study concluded that interventional radiology¿operated cholecystoscopy may serve as an effective method for percutaneous gallstone removal in patients with multiple comorbidities precluding cholecystectomy.One patient developed acute pancreatitis four days after the procedure.The pancreatitis was managed medically but was complicated by an exacerbation of congestive heart failure.The patient was hospitalized for 32 days.Although requested, additional information could not be provided.

Manufacturer Narrative

This report is being supplemented to provide additional information (h6, h10) regarding the reported event.Clinical/medical assessment: it was concluded that the reported complications are more likely to be conditions of the patients and there is no indication that the olympus device attributed to this complaint record was used on the patient who developed acute pancreatitis.A device history record review cannot be completed as the device serial number is unknown.Olympus will continue to monitor complaints for this device.

• Brand Name: SHOCKPULSE LITHOTRIPSY TRANSDUCER.
• Type of Device: LITHOTRIPTOR, ULTRASONIC
• Manufacturer (Section D): GYRUS ACMI INC; 136 turnpike road; southborough PA 01772
• MDR Report Key: 10391644
• MDR Text Key: 203123303
• Report Number: 3003790304-2020-00067
• Device Sequence Number: 1
• Product Code: FEO
• Combination Product (y/n): N
• PMA/PMN Number: K142428
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 09/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SPL-T
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening