MAUDE Adverse Event Report: KARL STORZ SE & CO. KG HOPKINS STRAIGHT FORWARD TELESCOPE 30º; 30º TELESCOPE

Model Number	26046BCA
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Per the hospital, they have followed up with both patients and made them aware of the incident and have prescribed antibiotics for them.The hospital also reports that both patients were released from the hospital and they are doing well.Also, per the hospital, neither patient is considered a high-risk patient, and both incidents are now being followed up and monitored by their infection disease and prevention experts.
Event or Problem Description
Our on-site endoscopic specialist reported that during two separate procedures on (b)(6) 2019 (a laparoscopic cholecystectomy and a laparoscopic appendectomy), an unsterilized scope was mistakenly used on patients in both cases; this report is for the lap appendectomy procedure.

• Brand Name: HOPKINS STRAIGHT FORWARD TELESCOPE 30º
• Common Device Name: 30º TELESCOPE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• MDR Report Key: 9593886
• Report Number: 9610617-2019-00123
• Device Sequence Number: 13576159
• Product Code: OWN
• UDI-Device Identifier: 04048551367346
• UDI-Public: 04048551367346
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: K171238
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/18/2019

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?: No
• Operator of Device: Health Professional
• Device Model Number: 26046BCA
• Device Catalogue Number: 26046BCA
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2019
• Initial Report FDA Received Date: 01/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other