MAUDE Adverse Event Report: KARL STORZ SE & CO. KG HOPKINS II 30º TELESCOPE; RIGID ENDOSCOPE

Model Number 27005BA

Device Problem Excessive Heating (4030)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The product involved has not yet been returned for evaluation.This event is filed under internal complaint id (b)(4).

Event Description

Customer reported that the scope is burnt.Problem occurred during a procedure; no injury to patient.

Manufacturer Narrative

Based on additional information received, this event was re-evaluated and is considered no longer reportable - no malfunction or serious injury, and the retrospective complaint review did not show any similar cases resulting in serious injury.

• Brand Name: HOPKINS II 30º TELESCOPE
• Type of Device: RIGID ENDOSCOPE
• 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 ave; el segundo, CA 90245-5017 ; 4242188738
• MDR Report Key: 15911427
• MDR Text Key: 305883087
• Report Number: 9610617-2022-00303
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04048551001066
• UDI-Public: 4048551001066
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K943176
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27005BA
• Device Catalogue Number: 27005BA
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/03/2022
• Initial Date FDA Received: 12/02/2022
• Supplement Dates Manufacturer Received: 11/03/2022
• Supplement Dates FDA Received: 12/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2021
• 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): Other
• Patient Sex: Male