MAUDE Adverse Event Report: KARL STORZ SE & CO. KG TUBING/FILTER SET, STERILE; INSUFFLATION HOSE WITH GAS FILTER

Model Number 031222-10

Device Problem Material Separation (1562)

Patient Problem Insufficient Information (4580)

Event Date 07/23/2021

Event Type  malfunction  

Manufacturer Narrative

The initial investigation (without product sent in to (b)(6)) was performed by evaluation of a photo documentation on (b)(6) 2021.According to the results, it could be confirmed that the hose was disconnected from its gas filter.A deeper investigation will be performed as soon as the tubing set is returned to the manufacturer.

Event Description

As per a manufacturer incident report we received from the factory in (b)(6) : during patient treatment, the gas hose had come off the filter.This led to a pressure drop of the pneumoperitoneum.The surgeon was in the abdomen with a sharp needle clamped in the needle holder.No harm or clinical consequences were reported.

Manufacturer Narrative

The final investigation was performed on 2021-01-17.According to the investigation results, it could be confirmed that the hose was detached from its filter.The most probable root cause is that the adhesive connection between hose and filter was not tight enough.Therefore, a manufacturing error cannot be excluded.As a result, a supplier complaint in conjunction to a 8d report was initiated.However, a complaint trend analysis did not show an increase of complaints for the affected article.

• Brand Name: TUBING/FILTER SET, STERILE
• Type of Device: INSUFFLATION HOSE WITH GAS FILTER
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• Manufacturer Contact: anja fair ; 2151 e. grand avenue; el segundo, CA 90245-5017 ; 4242188738
• MDR Report Key: 12447018
• MDR Text Key: 271884144
• Report Number: 9610617-2021-00063
• Device Sequence Number: 1
• Product Code: NKC
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 031222-10
• Device Catalogue Number: 031222-10
• Device Lot Number: W-032001
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2020
• 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
• Patient Outcome(s): Other
• Patient Age: 80 YR
• Patient Sex: Male