MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CLICKLINE INSULATED OUTER TUBE, 5MMX36CM

Model Number 33300

Device Problem Material Integrity Problem (2978)

Patient Problem Bowel Burn (1756)

Event Date 09/12/2020

Event Type  Injury  

Manufacturer Narrative

The device has not been received by the factory.

Event Description

As per a manufacturer incident report we received from the factory in (b)(4): intra-operative incident.(b)(6) year-old girl was having a laparoscopic appendectomy.After removal of the specimen, on diagnostic laparoscopy, two instrument burns on the small bowel were noted.On inspecting the instrument, 2 cracks were noted on the peatlands forceps, which coincided with the sites of the burns.

Manufacturer Narrative

Upon evaluation it could be confirmed that the insulation outer layer sheath was damaged.There are 2 holes on outer sheath.No indication for a material or manufacturing related issue was found during the investigation.The most potential root cause is due to mechanical damage to insulation layer which led to the hole.Current ifu has already included the instruction that the instrument needs to be checked for its suitability prior to use and warning to the risk of injury to patients if the insulation of instruments is damaged or missing.

Manufacturer Narrative

Data in section h6 have been corrected to match the evaluation findings.

• Brand Name: CLICKLINE INSULATED OUTER TUBE, 5MMX36CM
• Type of Device: INSULATED OUTER TUBE
• 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: susie chen ; 2151 e. grand avenue; el segundo, CA 90245-5017 ; 4242188201
• MDR Report Key: 10621468
• MDR Text Key: 209630337
• Report Number: 9610617-2020-00108
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04048551002308
• UDI-Public: 4048551002308
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K935071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 33300
• Device Catalogue Number: 33300
• Device Lot Number: YU15
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 11 YR
• Patient Sex: Female