MAUDE Adverse Event Report: KARL STORZ SE & CO. KG THERMOFLATOR SCB

Model Number 26432020-1

Device Problems Inflation Problem (1310); Infusion or Flow Problem (2964)

Patient Problem Bowel Perforation (2668)

Event Date 10/14/2019

Event Type  Injury  

Event Description

It was reported that there was event with a insufflator.According to the information received, theequipment oscillated the pressure management of the device during surgery and after the creation of a useful area the rupture of the bowel loop of the patient was verified.Mesentery injury prolongs hospitalization for 03 days, collaborator reports that material was checked for maintenance.Pressure and flow tests were performed as recommended by the manufacturer to verify the correct operation of the equipment.The equipment underwent a periodic preventive maintenance on 11/oct/2019 and as in the tests performed in this service it presented satisfactory results and all parameters observed were within the recommended by the manufacturer.It was verified in video (recorded by the circulator after authorization of the doctor) that at the moment of the intercourse the initialization mode was not activated, and that it was used a disposable veress needle, we suggest that at the beginning of the procedures the "pneumoperitoneum initialization" mode is activated, in this mode the pressure and flow insufflation patterns are preset, so the equipment is even more sensitive to external pressures preventing any damage to the patient, in relation to the materials used is recommended.Karl storz veress needle.

Manufacturer Narrative

Belated evaluation and reporting of this complaint was done during retrospective review as part of capa 22-0074 corrective action 12.No investigation possible, because no product returned.Complaint data was analyzed, no further similare failure description was found.Therefore no indication for a systematic failure.If the bowl ruptures, it indicated that a pressure increase inside the bowel occurred.The endoflator is insufflating inside the abdomen which would led to compression of the bowel and not an inflation.It is possible that an incorrect, in the bowel placed verres needle caused the event, which could not be confirmed.The event is filed under internal karl storz complaint id (b)(4).

• Brand Name: THERMOFLATOR SCB
• Type of Device: THERMOFLATOR SCB
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 17072490
• MDR Text Key: 316636820
• Report Number: 9610617-2023-00825
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K955073
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/06/2023

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 Model Number: 26432020-1
• Device Catalogue Number: 26432020-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/21/2019
• Initial Date FDA Received: 06/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization