MAUDE Adverse Event Report: KARL STORZ SE & CO. KG INSERT, SCISSORS, SERRATED JAWS; SINGLE USE SCISSORS, SERRATED JAWS

Model Number	34310MA-D
Medical Device Problem Code	Arcing of Electrodes (2289)
Health Effect - Clinical Code	Burn, Thermal (2530)
Date of Event	08/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The broken instrument has been returned but evaluation has not been completed.
Event or Problem Description
Allegedly, during a laparoscopic excision and fulguration of endometriosis procedure, toward the end of the procedure, the doctor "zapped a bleeder to cauterize".When the doctor pulled the instrument away the burns were noticed.The procedure was completed, no other intervention was required.
Additional Manufacturer Narrative
The instrument was manufactured in 02/2016 and evaluation of the instrument determined the insulation is torn at the distal end.We suspect this single use item might have be re-used.

• Brand Name: INSERT, SCISSORS, SERRATED JAWS
• Common Device Name: SINGLE USE SCISSORS, SERRATED JAWS
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, gm,
• MDR Report Key: 9100427
• Report Number: 9610617-2019-00082
• Device Sequence Number: 14109212
• Product Code: GEI
• UDI-Device Identifier: 04048551336434
• UDI-Public: 4048551336434
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K151044
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2019

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: 34310MA-D
• Device Catalogue Number: 34310MA-D
• Device Lot Number: OT01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2019
• Initial Date Received by Manufacturer: 08/21/2019
• Supplement Date Received by Manufacturer: 08/21/2019
• Initial Report FDA Received Date: 09/20/2019
• Supplement Report FDA Received Date: 10/04/2019
• 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: Required Intervention
• Patient Age: 30 YR
• Patient Weight: 103