MAUDE Adverse Event Report: RICHARD WOLF GMBH PANOVIEW ULTRA; TELESCOPE Ø 5.5MM WL 300MM REUSABLE

Model Number	8935462
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is on-going.The user facility will be contacted to obtain additional information.A follow up will be submitted upon receipt of additional information.
Event or Problem Description
It was reported that post procedure- gastric sleeve operation.Patient presented with an abdominal burn wound post-operative.This lesion was caused by the heated lens.The same lightcable and lens were connected a day afterwards to test and it was extremely hot.

• Brand Name: PANOVIEW ULTRA
• Common Device Name: TELESCOPE Ø 5.5MM WL 300MM REUSABLE
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 10284884
• Report Number: 9611102-2020-00013
• Device Sequence Number: 2853950
• Product Code: GCJ
• UDI-Device Identifier: 04055207058152
• UDI-Public: 04055207058152
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• PMA/510(K) Number: K941541
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/19/2020

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: 8935462
• Device Catalogue Number: 8935462
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/17/2020
• Initial Report FDA Received Date: 07/16/2020
• 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