MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CLICKLINE OUTER TUBE WITH WORKING KELLY DISSECTING/GRASPING FORCEPS INSERT; OUTER TUBE W/FORCEPS INSERT

Model Number	30710MD
Medical Device Problem Codes	Material Frayed (1262); Scratched Material (3020)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer has returned the device; however, we have not yet received it.A supplemental report will be submitted once it is received and the evaluation is completed.
Event or Problem Description
We learned from medwatch report #mw5078564 received via mail on (b)(6) 2018 that, allegedly, during a procedure on (b)(6) 2018, the dissecting/grasping forceps broke and pieces fell into the patient.The procedure was a fowler-stephens orchiopexy procedure.An x-ray taken was negative and customer confirmed the patient was fine post-op.
Additional Manufacturer Narrative
The model number reported in the initial medwatch report # 33310mds, was incorrect; the customer actually returned model number # 30710md.We evaluated the returned device and found that portions of the insulation along the shaft are missing.It looks like the missing insulation was scraped off when the device was removed from the patient through the cannula.We assume it was pieces of the insulation that came off into the patient.In addition, the jaws are bent and the jaws pin is loose.The instrument had been in use for almost 10 years.

• Brand Name: CLICKLINE OUTER TUBE WITH WORKING KELLY DISSECTING/GRASPING FORCEPS INSERT
• Common Device Name: OUTER TUBE W/FORCEPS INSERT
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• MDR Report Key: 7851272
• Report Number: 9610617-2018-00069
• Device Sequence Number: 1130115
• Product Code: GCJ
• UDI-Device Identifier: 04048551121771
• UDI-Public: 4048551121771
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K935071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2018

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
• Operator of Device: Health Professional
• Device Model Number: 30710MD
• Device Catalogue Number: 30710MD
• Device Lot Number: KB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2018
• Initial Date Received by Manufacturer: 08/07/2018
• Supplement Date Received by Manufacturer: 08/07/2018
• Initial Report FDA Received Date: 09/06/2018
• Supplement Report FDA Received Date: 03/05/2019
• 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